Orphan Products Designations and Approvals List

Through

February 2001

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

1,5-(Butylimino)-1,5 Treatment of Fabry\'s disease. Oxford GlycoSciences

dideoxy,D-glucitol 10, The Quadrant

TN= Abington Science Park, Abington

Oxfordshire OX14 3YS UK

DD= 5/12/98 MA=

1,5-(Butylimino)-1,5 Treatment of Gaucher disease. Oxford GlycoSciences

dideoxy,D-glucitol 10, The Quadrant

TN= Abington Science Park, Abington

Oxfordshire OX14 3YS UK

DD= 5/29/98 MA=

1-(11-dodecylamino-10-hy Treatment of hormone refractory Cell
Therapeutics, Inc.

droxyundecyl)-3,7-dimeth prostate carcinoma. 201 Elliott Avenue West

TN= Suite 400

Seattle WA 98119

DD= 1/18/00 MA=

111Indium pentetreotide Treatment of somatostatin receptor Louisiana
State University

positive neuroendocrine tumors. 1600 Canal St.

TN= SomatoTher 10th Floor

New Orleans LA 70112

DD= 6/10/99 MA=

15AU81 Treatment of pulmonary arterial United Therapeutics Corp.

hypertension. 68 T.W. Alexander Dr.

TN= P.O. Box 14186

Research Triangle Park NC 27709

DD= 6/4/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

166Ho-DOTMP Treatment of multiple myeloma. NeoRx Corporation

410 W. Harrison Street

TN= Seattle WA 98119-4007

DD= 2/10/99 MA=

2\'-3\'-dideoxyadenosine Treatment of aquired National Cancer Institute,
Dct

immunodeficiency syndrome. NIH, Exec. Plaza N., Room 7-18

TN= Bethesda MD 20892

DD= 7/21/87 MA=

2\'-deoxycytidine As a host-protective agent in the Grant, Steven M.D.

treatment of acute myelogenous Massey Cancer Center, VCU

TN= leukemia. P.O. Box 980230

Richmond VA 23298-0230

DD= 9/9/96 MA=

2-0-desulfated heparin Treatment of cystic fibrosis. Kennedy & Hoidal,
M.D.\'s

University of Utah Health

TN= Aeropin 50 North Medical Drive, Room

Salt Lake City UT 84132

DD= 9/17/93 MA=

24,25 Treatment of uremic osteodystrophy. Lemmon Company

dihydroxycholecalciferol 1510 Delp Drive

TN= Kulpsville PA 19443

DD= 2/27/87 MA=

3\'-azido-2\',3\'dideoxyuri Treatment of acquired Berlex Laboratories,
Inc.

dine immunodeficiency syndrome. 1401 Harbor Bay Parkway

TN= AZDU Alameda CA 94501

DD= 11/20/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

3,4-diaminopyridine Treatment of Lambert-Eaton Jacobus Pharmaceutical
Company

myasthenic syndrome. 37 Cleveland Avenue

TN= P.O. Box 5290

Princeton NJ 08540

DD= 12/18/90 MA=

3,5,3\'-triiodothyroaceta Treatment of well-differentiated Elliot
Danforth, Jr., M.D.

te papillary, follicular or combined University of Vermont

TN= papillary/follicular carcinomas of 84 Beartown Road

the thyroid gland.

Underhill VT 05489

DD= 9/20/99 MA=

3-(3,5-Dimethyl-1H-2ylme Treatment of von Hippel-Lindau Sugen, Inc.

thylene)-1,3-dihydro-ind disease. 230 East Grand Ave.

TN= South San Francisco CA 94080

DD= 3/23/00 MA=

3-(3,5-dimethyl-1H-2ylme Treatment of Kaposi\'s sarcoma. Sugen, Inc.

thylene)-1,3-dihydro-ind 230 East Grand Ave.

TN= South San Francisco CA

DD= 9/11/98 MA=

4-aminosalicylic acid Treatment of mild to moderate Beeken, Warren M.D.

ulcerative colitis in patients University Of Vermont

TN= Pamisyl (P-D), intolerant to sulfasalazine. Given C-317

Burlington VT 05405

DD= 12/13/89 MA=

40SD02 Treatment of chronic iron overload Biomedical Frontiers, Inc.

resulting from conventional 1095 10th Ave., S.E.

TN= transfusional treatment of Minneapolis MN 55414

beta-thalassemia major and sickle

cell anemia.

DD= 12/21/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

5,6-dihydro-5-azacytidin Treatment of malignant ILEX Oncology, Inc.

e mesothelioma. 4545 Horizon Hill Blvd.

TN= San Antonio TX 78229-2263

DD= 5/11/92 MA=

5-aza-2\'-deoxycytidine Treatment of acute leukemia. Pharmachemie
U.S.A., Inc.

1510 Delp Dr.

TN= Kulpsville PA 19443

DD= 8/3/87 MA=

506U78 Treatment of chronic lymphocytic Glaxo Wellcome, Inc.

leukemia. Five Moore Dr.

TN= P.O. Box 13398

Research Triangle Park NC

DD= 9/2/99 MA=

5a8, monoclonal antibody For use in post-exposure Biogen, Inc.

to CD4 prophylaxis for occupational 14 Cambridge Center

TN= exposure to human immunodeficiency Cambridge MA 02142

virus.

DD= 12/20/93 MA=

6-hydroxymethylacylfulve Treatment of histologically MGI Pharma, Inc.

ne confirmed advanced or metastatic 6300 West Old Shakoppe Rd.

TN= pancreatic cancer. Suite 110

Bloomington MN 55438-2318

DD= 4/6/99 MA=

6-hydroxymethylacylfulve Treatment of renal cell carcinoma. MGI Pharma,
Inc.

ne 6300 West Old Shakoppe Rd.

TN= Suite 110

Bloomington MN 55438-2318

DD= 7/27/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

6-hydroxymethylacylfulve Treatment of ovarian cancer. MGI Pharma, Inc.

ne 6300 West Old Shakoppe Rd.

TN= Suite 110

Bloomington MN 55438-2318

DD= 7/6/99 MA=

8 Cyclopentyl Treatment of cystic fibrosis. SciClone Pharmaceuticals,
Inc.

1,3-dipropylxanthine 901 Mariner\'s Island Boulevard

TN= San Mateo CA 94404-1593

DD= 3/24/97 MA=

8-methoxsalen For use in conjunction with the Therakos, Inc.

UVAR photopheresis to treat diffuse Oaklands Corporate Center

TN= Uvadex systemic sclerosis. 437 Creamery Way

Exton PA 19341

DD= 6/22/93 MA=

8-methoxsalen For the prevention of acute Therakos, Inc.

rejection of cardiac allografts. Oaklands Corporate Center

TN= Uvadex 437 Creamery Way

Exton PA 19341

DD= 5/12/94 MA=

9-cis retinoic acid Treatment of acute promyelocytic Ligand
Pharmaceuticals, Inc.

leukemia. 9393 Towne Centre Drive

TN= Panretin Suite 100

San Diego CA 92121

DD= 4/10/92 MA=

9-cis-retinoic acid Prevention of retinal detachment Allergan, Inc.

due to proliferative 2525 Dupont Drive

TN= vitreoretinopathy. P.O. Box 19534

Irvine CA 92623-9534

DD= 1/2/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

9-nitro-20-(S)-camptothe Treatment of pancreatic cancer. Stehlin
Foundation for Cancer

cin 1315 St. Joseph Parkway, Suite

TN= Houston TX 77002

DD= 9/16/96 MA=

A Treatment of Friedreich\'s and other Forest Pharmaceuticals, Inc.

inherited ataxias. 150 East 58th Street

TN= Antilirium New York NY 10155

DD= 1/16/85 MA=

Abetimus Treatment of lupus nephritis. La Jolla Pharmaceutical Co.

6455 Nancy Ridge Dr.

TN= San Diego CA 92121

DD= 7/28/00 MA=

Acetylcysteine Intravenous treatment of patients Apothecon

presenting with moderate to severe P.O. Box 4500

TN= Mucomyst/Mucomyst 10 acetaminophen overdose. Princeton NJ 08543-4500

DD= 8/13/87 MA=

Aconiazide Treatment of tuberculosis. Lincoln Diagnostics

P.O. Box 1128

TN= Decatur IL 62525

DD= 6/20/88 MA=

Adeno-associated Treatment of cystic fibrosis. Targeted Genetics
Corporation

viral-based vector 1100 Olive Way, Suite 100

TN= Seattle WA 98101

DD= 2/15/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Adenosine For use in conjunction with BCNU in Medco Research, Inc.

the treatment of brain tumors. 8455 Beverly Boulevard

TN= Suite 308

Los Angeles CA 90048

DD= 8/1/89 MA=

Adenovirus-based vector Treatment of hemophilia A. GenStar Therapeutics
Corporation

Factor VIII 10835 Altman Row

TN= MiniAdFVIII Suite 150

San Diego CA 92121

DD= 12/15/99 MA=

Aerosolized pooled Treatment of respiratory syncytial Pediatric
Pharmaceuticals, Inc.

immune globulin virus lower respiratory tract 718 Bradford Avenue

TN= disease. Westfield NJ 07090

DD= 1/3/89 MA=

AI-RSA Treatment of autoimmune uveitis. AutoImmune, Inc.

128 Spring Street

TN= Lexington MA 02173

DD= 10/8/92 MA=

Albendazole Treatment of hydatid disease SmithKline Beecham

(cystic echinococcosis due to E. One Franklin Plaza

TN= Albenza granulosus larvae or alveolar P.O. Box 7929

echinococcosis due to E.

multilocularis larvae). Philadelphia PA 19101

DD= 1/17/96 MA= 6/11/96

Albendazole Treatment of neurocysticercosis due SmithKline Beecham

to Taenia solium as: 1) One Franklin Plaza

TN= Albenza chemotherapy of parenchymal, P.O. Box 7929

subarachnoidal and racemose (cysts

in spinal fluid) neurocysticercosis Philadelphia PA 19101

in symptomatic cases and 2)

DD= 1/18/96 MA= 6/11/96

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Aldesleukin For the treatment non-Hodgkin\'s Chiron Corporation

lymphoma. 4560 Horton St.

TN= Proleukin Emeryville CA 94608-2916

DD= 11/24/98 MA=

Aldesleukin Treatment of primary Chiron Corporation

immunodeficiency disease associated 4560 Horton Street

TN= Proleukin with T-cell defects. Emeryville CA 94608-2916

DD= 3/22/89 MA=

Aldesleukin Treatment of metastatic renal cell Chiron Corporation

carcinoma. 4560 Horton Street

TN= Proleukin Emeryville CA 94608-2916

DD= 9/14/88 MA= 5/5/92

Aldesleukin Treatment of metastatic melanoma. Chiron Corporation

4560 Horton Street

TN= Proleukin Emeryville CA 94608-2916

DD= 9/10/96 MA= 1/9/98

Aldesleukin Treatment of acute myelogenous Chiron Corporation

leukemia. 4560 Horton St.

TN= Proleukin Emeryville CA 94608-2916

DD= 7/31/98 MA=

alemtuzumab Treatment of chronic lymphocytic Millennium and ILEX
Partners, LP

leukemia. 75 Sidney Street

TN= Campath Cambridge MA 02138

DD= 10/20/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Alendronate disodium Treatment of the bone Richard J. Wenstrup, M.D.

manifestations of Gaucher disease Division of Human Genetics

TN= Fosamax Children\'s Hospital Research

Cincinnati OH 45229-3039

DD= 2/13/01 MA=

Alglucerase injection Replacement therapy in patients Genzyme
Corporation

with Type II and III Gaucher\'s One Kendall Square

TN= Ceredase disease. Cambridge MA 02139-1562

DD= 7/21/95 MA=

Alglucerase injection For replacement therapy in patients Genzyme
Corporation

with Gaucher\'s disease type I. One Kendall Square

TN= Ceredase Cambridge MA 02139-1562

DD= 3/11/85 MA= 4/5/91

Alitretinoin Topical treatment of cutaneous Ligand Pharmaceuticals Inc.

lesions in patients with 10275 Science Center Drive

TN= Panretin AIDS-related Kaposi\'s sarcoma. San Diego CA 92121-1117

DD= 3/24/98 MA= 2/2/99

Allogeneic human retinal Treatment of Hoehn and Yahr stage 3 Titan
Pharmaceuticals, Inc.

pigment epithelial and 4 Parkinson\'s disease. Post Office Plaza

TN= Spheramine 50 Division Street, Suite 503

Somerville NJ 08876

DD= 7/18/97 MA=

Allogeneic peripheral Treatment of pancreatic cancer. Applied
Immunotherapeutics, LLC

blood mononuclear cells 14132 E. Firestone Boulevard

TN= CYTOIMPLANT Santa Fe Springs CA 90670

DD= 6/13/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Allopurinol riboside Treatment of cutaneous and visceral Burroughs
Wellcome Company

leishmaniasis. 3030 Cornwallis Road

TN= P.O. Box 12700

Research Triangle Park NC 27709

DD= 12/4/85 MA=

Allopurinol riboside Treatment of Chagas\' disease. Burroughs Wellcome
Company

3030 Cornwallis Road

TN= P.O. Box 12700

Research Triangle Park NC 27709

DD= 12/4/85 MA=

Allopurinol sodium Management of patients with Catalytica
Pharmaceuticals, Inc

leukemia, lymphoma, and solid tumor PO Box 1887

TN= Zyloprim malignancies who are receiving Greenville NC 27835-1887

cancer therapy which causes

elevations of serum and urinary

uric acid levels and who cannot

DD= 10/16/92 MA= 5/17/96

Allopurinol sodium Ex-vivo preservation of cadaveric Burroughs Wellcome
Company

kidneys for transplantation 3030 Cornwallis Road

TN= Zyloprim Research Triangle Pk NC 27709

DD= 11/9/87 MA=

Alpha-1-antitrypsin As supplementation therapy for Chiron Corporation

(recombinant DNA Origin) alpha-1-antitrypsin deficiency in 4560 Horton
Street

TN= the ZZ phenotype population. Emeryville CA 94608-2916

DD= 1/1/84 MA=

Alpha-galactosidase A Treatment of Fabry\'s disease. Desnick, Robert J.
M.D.

The Mount Sinai School Of

TN= Fabrase Fifth Avenue at 100th Street,

New York NY 10029

DD= 7/20/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Alpha-galactosidase A Treatment of alpha-galactosidase A Orphan Medical,
Inc.

deficiency (Fabry\'s disease). 13911 Ridgedale Drive

TN= CC-galactosidase Suite 475

Minnetonka MN 55305

DD= 6/17/91 MA=

Alpha-galactosidase A Long-term enzyme replacement Transkaryotic
Therapies Inc.

therapy for the treatment of Fabry 195 Albany St.

TN= Replagal disease. Cambridge MA 02139

DD= 6/22/98 MA=

Alpha-melanocyte Prevention and treatment of National Institute of
Diabetes,

stimulating hormone intrinsic acute renal failure due National
Institutes of Health,

TN= to ischemia. Building 31, Room 9N-222

Bethesda MD 20892-2560

DD= 8/19/97 MA=

Alpha1-proteinase For slowing the progression of Aventis Behring L.L.C.

inhibitor (human) emphysema in alpha1-antitrypsin 1020 First Ave.

TN= deficient patients. PO Box 61501

King of Prussia PA 19406-0901

DD= 11/24/99 MA=

Alpha1-proteinase For replacement therapy in the Bayer Corporation

inhibitor (human) alpha-1-proteinase inhibitor Pharmaceutical Division,

TN= Prolastin congenital deficiency state. 400 Morgan Lane

New Haven CT 06516

DD= 12/7/84 MA= 12/2/87

Alprostadil Treatment of severe peripheral Schwarz Pharma, Inc.

arterial occlusive disease P.O. Box 2038

TN= (critical limb ischemia) in Milwaukee WI 53201

patients where other procedures,

grafts or angioplasty, are not

indicated.

DD= 10/20/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Alronidase Treatment of patients with BioMarin Pharmaceutical, Inc.

mucopolysaccharidosis-I. 371 Bel Marin Keys Boulevard,

TN= Aldurazyme Novato CA 94949-5608

DD= 9/24/97 MA=

Altretamine Treatment of advanced Medimmune Oncology, Inc.

adenocarcinoma of the ovary. One Tower Bridge

TN= Hexalen 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 2/9/84 MA= 12/26/90

Amifostine For the reduction of the incidence Medimmune Oncology, Inc.

and severity of toxicities One Tower Bridge

TN= Ethyol associated with cisplatin 100 Front St., Suite #400

administration.

West Conshohocken PA 19428

DD= 11/24/98 MA=

Amifostine Treatment of myelodysplastic Medimmune Oncology, Inc.

syndromes. One Tower Bridge

TN= Ethyol 100 Front St., Suite 400

West Conshohocken PA 19428

DD= 10/4/99 MA=

Amifostine Reduction of the incidence of Medimmune Oncology, Inc.

moderate to severe xerostomia in One Tower Bridge

TN= Ethyol patients undergoing post-operative 100 Front Street, Suite
400

radiation treatment for head and

neck cancer. Conshohocken PA 19428

DD= 5/12/98 MA= 6/24/99

Amifostine For use as a chemoprotective agent Medimmune Oncology, Inc.

for cisplatin in the treatment of One Tower Bridge

TN= Ethyol advanced ovarian carcinoma. 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 5/30/90 MA= 12/8/95

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Amifostine For use as a chemoprotective agent Medimmune Oncology, Inc.

for cisplatin in the treatment of One Tower Bridge

TN= Ethyol metastatic melanoma. 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 5/30/90 MA=

Amifostine For use as a chemoprotective agent Medimmune Oncology, Inc.

for cyclophosphamide in the One Tower Bridge

TN= Ethyol treatment of advanced ovarian 100 Front Street, Suite 400

carcinoma.

West Conshohocken PA 19428

DD= 5/30/90 MA=

Amiloride HCl solution Treatment of cystic fibrosis. Glaxo Wellcome
Research and

for inhalation 5 Moore Drive

TN= PO Box 13398

Research Triangle Park NC 27709

DD= 7/18/90 MA=

Aminocaproic acid For the topical treatment of Eastern Virginia Medical
School

traumatic hyphema of the eye. Department of Ophthalomology

TN= Caprogel 880 Kempsville Road, Suite 2500

Norfolk VA 23502-3990

DD= 1/6/95 MA=

Aminosalicylate sodium Treatment of Crohn\'s disease. Syncom
Pharmaceuticals, Inc.

66 Hanover Road

TN= Florham Park NJ 07932

DD= 4/6/93 MA=

Aminosalicylic acid Treatment of tuberculosis Jacobus Pharmaceutical
Company

infections. 37 Cleveland Lane

TN= Paser Granules P.O. Box 5290

Princeton NJ 08540

DD= 2/19/92 MA= 6/30/94

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Aminosidine Treatment of visceral leishmaniasis Kanyok, Thomas P.
Pharm.D.

(kala-azar). University of Illinois at

TN= Paromomycin 833 South Wood Street (m/c886)

Chicago IL 60612

DD= 9/9/94 MA=

Aminosidine Treatment of Mycobacterium avium Kanyok, Thomas P. Pharm.D.

complex. University of Illinois at

TN= Gabbromicina 833 South Wood Street (m/c886)

Chicago IL 60612

DD= 11/15/93 MA=

Aminosidine Treatment of tuberculosis. Kanyok, Thomas P. Pharm.D.

University Of Illinois At

TN= Gabbromicina 833 South Wood Street (m/c886)

Chicago IL 60612

DD= 5/14/93 MA=

Amiodarone Treatment of incessant ventricular Wyeth-Ayerst Research

tachycardia. PO Box 8299

TN= Amio-Aqueous Philadelphia PA 19101-8299

DD= 8/17/93 MA=

Amiodarone HCl For the acute treatment and Wyeth-Ayerst Laboratories

prophylaxis of life-threatening P.O. Box 8299

TN= Cordarone ventricular tachycardia or Philadelphia PA 19101

ventricular fibrillation.

DD= 3/16/94 MA= 8/3/95

Ammonium Treatment of Wilson\'s disease. Brewer, George J. M.D.

tetrathiomolybdate University Of Michigan Medical

TN= 4708 Medical Science Building II

Ann Arbor MI 48109

DD= 1/31/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Amphotericin B lipid Treatment of invasive The Liposome Company, Inc.

complex sporotrichosis. One Research Way

TN= Abelcet Princeton NJ 08540

DD= 9/23/96 MA=

Amphotericin B lipid Treatment of invasive fungal Liposome Company, Inc.

complex infections. One Research Way

TN= Abelcet Princeton NJ 08540

DD= 12/3/96 MA= 10/18/96

Amphotericin B lipid Treatment of invasive zygomycosis. The Liposome
Company, Inc.

complex One Research Way

TN= Abelcet Princeton NJ 08540

DD= 5/6/96 MA=

Amphotericin B lipid Treatment of invasive candidiasis. The Liposome
Company, Inc.

complex One Research Way

TN= Abelcet Princeton NJ 08540

DD= 6/27/96 MA=

Amphotericin B lipid Treatment of invasive The Liposome Company, Inc.

complex protothecosis. One Research Way

TN= Abelcet Princeton NJ 08540

DD= 8/21/96 MA=

Amphotericin B lipid Treatment of invasive The Liposome Company, Inc.

complex coccidioidomycosis. One Research Way

TN= Abelcet Princeton NJ 08540

DD= 5/6/96 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Amsacrine Treatment of acute adult leukemia. Warner-Lambert Company

Parke-Davis Pharmaceutical

TN= Amsidyl 2800 Plymouth Road

Ann Arbor MI 48106

DD= 12/7/84 MA=

Anagrelide Treatment of polycythemia vera. Roberts Pharmaceutical Corp.

Meridian Center II

TN= Agrylin 4 Industrial Way West

Eatontown NJ 07724-2274

DD= 6/11/85 MA=

Anagrelide Treatment of thrombocytosis in Roberts Pharmaceutical Corp.

chronic myelogenous leukemia. Meridian Center II

TN= Agrylin 4 Industrial Way West

Eatontown NJ 07724-2274

DD= 7/14/86 MA=

Anagrelide Treatment of essential Roberts Pharmaceutical Corp.

thrombocythemia. Meridian Center III

TN= Agrylin 6 Industrial Way West

Eatontown NJ 07724

DD= 1/27/88 MA= 3/14/97

Ananain, comosain For the enzymatic debridement of Genzyme Corporation

severe burns. One Kendall Square

TN= Vianain Cambridge MA 02139

DD= 1/21/92 MA=

Anaritide acetate Improvement of early renal Scios, Inc.

allograft function following renal 2450 Bayshore Parkway

TN= Auriculin transplantation. Mountain View CA 94043

DD= 4/10/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Anaritide acetate Treatment of patients with acute Scios, Inc.

renal failure. 2450 Bayshore Parkway

TN= Auriculin Mountain View CA 94043

DD= 8/27/92 MA=

Ancestim For use in combination with Amgen, Inc.

filgrastim to decrease the number One Amgen Center Drive

TN= Stemgen of phereses required to collect Thousand Oaks CA 91320-1799

peripheral blood progenitor cells

capable of providing rapid

multi-lineage hematopoietic

DD= 7/5/95 MA=

Ancrod To establish and maintain Knoll Pharmaceutical Company

anticoagulation in 3000 Continental Dr., North

TN= Viprinex heparin-intolerant patients Mt. Olive NJ 07828

undergoing cardiopulmonary bypass.

DD= 11/12/97 MA=

Angiotensin 1-7 Treatment of neutropenia associated Maret
Pharmaceuticals

with autologous bone marrow 4041 MacArthur Blvd.

TN= transplantation. Suite 375

Newport Beach CA 92660

DD= 2/16/00 MA=

Anti pan T lymphocyte For in-vivo treatment of bone Xoma Corporation

monoclonal antibody marrow recipients to prevent graft 2910 Seventh
Street

TN= Anti-t Lymphocyte rejection and graft versus host Berkeley CA 94710

disease.

DD= 1/29/86 MA=

Anti pan T lymphocyte For ex-vivo treatment to eliminate Xoma
Corporation

monoclonal antibody mature T cells from potential bone 2910 Seventh
Street

TN= Anti-t Lymphocyte marrow grafts. Berkeley CA 94710

DD= 1/29/86 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Anti-CD45 monoclonal Prevention of acute graft rejection Baxter
Healthcare Corporation

antibodies of human organ transplants. 1620 Waukegan Road

TN= Mcgaw Park IL 60085

DD= 9/10/90 MA=

Anti-cytomegalovirus Prevention of human cytomegalovirus Biomedical
Research Institute

monoclonal antibodies infection in patients diagnosed 345 North Smith
Avenue

TN= with AIDS. St. Paul MN 55102

DD= 5/3/90 MA=

Anti-cytomegalovirus Treatment of human cytomegalovirus Biomedical
Research Institute

monoclonal antibodies infection in patients diagnosed 345 North Smith
Avenue

TN= with AIDS. St. Paul MN 55102

DD= 5/3/90 MA=

Anti-cytomegalovirus Prevention of human cytomegalovirus Biomedical
Research Institute

monoclonal antibodies infection in bone marrow and organ 345 North Smith
Avenue

TN= transplant patients. St. Paul MN 55102

DD= 5/2/90 MA=

Anti-cytomegalovirus Treatment of human cytomegalovirus Biomedical
Research Institute

monoclonal antibodies infection in bone marrow and organ 345 North Smith
Avenue

TN= transplant patients. St. Paul MN 55102

DD= 5/2/90 MA=

Anti-tap-72 immunotoxin Treatment of metastatic colorectal Xoma
Corporation

adenocarcinoma. 2910 Seventh Street

TN= Xomazyme-791 Berkeley CA 94710

DD= 3/6/87 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Anti-thymocyte Globulin Treatment of myelodysplastic SangStat Medical
Corporation

(Rabbitt) syndrome (MDS) 6300 Dumbarton Circle

TN= Thymoglobulin Freemont CA 94555

DD= 9/6/00 MA=

Anti-thymocyte serum Treatment of allograft rejection, Applied Medical
Research

including solid organ (kidney, 1600 Hayes Street

TN= Nashville Rabbit liver, heart, lung, and pancreas) Nashville TN
37203

and bone marrow transplantation.

DD= 6/2/93 MA=

Antiepilepsirine Treatment of drug resistant Children\'s Hospital

generalized tonic-clonic epilepsy 700 Children\'s Drive

TN= in children and adults. Columbus OH 43205

DD= 3/23/89 MA=

Antihemophilic factor Treatment of von Willebrand\'s Alpha Therapeutic
Corporation

(human) disease. 5555 Valley Boulevard

TN= Alphanate Los Angeles CA 90032-3520

DD= 1/5/96 MA=

Antihemophilic factor Prophylaxis and treatment of Bayer Corporation

(recombinant) bleeding in individuals with 1884 Miles Avenue

TN= Kogenate hemophilia A or for prophylaxis Elkhart IN 46515

when surgery is required in

individuals with hemophilia A.

DD= 9/25/89 MA= 2/25/93

Antihemophilic factor For the control and prevention of Genetics
Institute, Inc.

(recombinant) hemorrhagic episodes and for 87 CambridgePark Drive

TN= ReFacto surgical prophylaxis in patients Cambridge MA 02140

with hemophilia A (congenital

factor VIII deficiency or classic

hemophilia).

DD= 2/8/96 MA= 3/6/00

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Antihemophilic Treatment and prevention of Aventis Behring L.L.C.

factor/von Willebrand bleeding in hemophilia A (classical 1020 First
Avenue

TN= Humate-P hemophilia) in adult patients; and PO Box 61501

treatment of spontaneous and

trauma-induced bleeding episodes in King Of Prussia PA 19406-0901

severe von Willebrand disease, and

DD= 10/16/92 MA= 4/1/99

Antimelanoma Antibody Diagnostic use in imaging systemic Xoma
Corporation

XMMME-001-DTPA 111 and nodal melanoma metastasis. 2910 Seventh Street

TN= Antimelanoma Berkeley CA 94710

DD= 11/14/84 MA=

Antimelanoma Antibody Treatment of stage III melanoma not Xoma
Corporation

XMMME-001-RTA amenable to surgical resection. 2910 Seventh Street

TN= Antimelanoma Berkeley CA 94710

DD= 11/14/84 MA=

Antipyrine Test For use as an index of hepatic Upsher-Smith
Laboratories, Inc

drug-metabolizing capacity. 4905 23rd Avenue North

TN= Minneapolis MN 55447

DD= 2/21/85 MA=

Antithrombin III (human) For replacement therapy in Bayer Corporation

congenital deficiency of AT-III for Pharmaceutical Division,

TN= Thrombate III prevention and treatment of 400 Morgan Lane

thrombosis and pulmonary emboli.

New Haven CT 06516

DD= 11/26/84 MA= 12/30/91

Antithrombin III (human) For the treatment of patients with Pharmacia &
Upjohn AB

hereditary antithrombin III Lindhagensgatan 133

TN= ATnativ deficiency in connection with SE-112 87 Stockholm

surgical or obstetrical procedures

or when they suffer from Sweden SE

thromboembolism.

DD= 2/8/85 MA= 12/31/89

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Antithrombin III (human) For prophylaxis and treatment of Aventis
Behring L.L.C.

concentrate IV thromboembolic episodes in patients 1020 First Ave.

TN= Kybernin P with genetic AT-III deficiency. PO Box 61501

King of Prussia PA 19406-0901

DD= 7/2/85 MA=

Antithrombin III human Preventing or arresting episodes of American
National Red Cross

thrombosis in patients with 9312 Old Georgetown Road

TN= Antithrombin III congenital AT-III deficiency and/or Bethesda MD
20814

to prevent the occurrence of

thrombosis in patients with AT-III

deficiency who have undergone

DD= 1/2/86 MA=

Antivenin, crotalidae Treatment of envenomations Protherics, Inc.

polyvalent immune Fab inflicted by North American 1207 17th Ave. S.,
Suite 103

TN= CroFab crotalid snakes. Nashville TN 37212

DD= 1/12/94 MA= 10/2/00

Antivenom (crotalidae) Treatment of envenomation by Ophidian
Pharmaceuticals, Inc.

purified (avian) poisonous snakes belonging to the 5445 East Cheryl
Parkway

TN= Crotalidae family. Madison WI 53711

DD= 2/12/91 MA=

AP1903 Treatment of acute Ariad Gene Therapeutics, Inc.

graft-versus-host disease in 26 Landsdowne St.

TN= patients undergoing bone marrow Cambridge MA 02139-4234

transplantation.

DD= 11/24/99 MA=

APL 400-020 V-Beta DNA Treatment of cutaneous T cell Wyeth-Lederle
Vaccines and

vaccine lymphoma. 211 Bailey Rd.

TN= West Henrietta NY 14586-9728

DD= 3/8/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Apomorphine For use as rescue treatment for Scherer DDS

early morning motor dysfunction in Frankland Road

TN= late-stage Parkinson\'s disease. Swindon SN5 8RU

Wiltshire UK

DD= 10/20/97 MA=

Apomorphine Treatment of the on-off Pentech Pharmaceuticals, Inc.

fluctuations associated with 1110 Lake Cook Rd.

TN= late-stage Parkinson\'s disease. Suite 257

Buffalo Grove IL 60089

DD= 7/17/95 MA=

Apomorphine HCl Treatment of the on-off Mylan Pharmaceuticals, Inc.

fluctuations associated with 781 Chestnut Ridge Rd.

TN= late-stage Parkinson\'s disease. PO Box 4310

Morgantown WV 26505-4310

DD= 4/22/93 MA=

Aprotinin For prophylactic use to reduce Bayer Corporation

perioperative blood loss and the Pharmaceutical Division

TN= Trasylol homologous blood transfusion 400 Morgan Lane

requirement in patients undergoing

cardiopulmonary bypass surgery in West Haven CT 06516

the course of repeat coronary

DD= 11/17/93 MA= 12/29/93

Arcitumomab Diagnosis and localization of Immunomedics, Inc.

primary, residual, recurrent and 300 American Road

TN= 99m Tc-labeled metastatic medullary thyroid Morris Plains NJ 07950

carcinoma.

DD= 5/10/96 MA=

Arginine butyrate Treatment of sickle cell disease Vertex
Pharmaceuticals Inc.

and beta thalassemia. 130 Waverly Street

TN= Cambridge MA 02139-4242

DD= 5/25/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Arginine butyrate Treatment of Perrine, Susan P., M.D.

beta-hemoglobinopathies and Boston University

TN= beta-thalassemia. Cancer Research Center

Boston MA 02118

DD= 4/7/92 MA=

Arsenic trioxide Treatment of multiple myeloma. Cell Therapeutics, Inc.

201 Elliott Ave. West, Suite

TN= Trisenox Seattle WA 98119

DD= 4/28/00 MA=

arsenic trioxide Treatment of myelodysplastic Cell Therapeutics, Inc.

syndrome. 201 Elliott Avenue West

TN= Trisenox Suite 400

Seattle WA 98119

DD= 7/17/00 MA=

Arsenic trioxide Treatment of acute promyelocytic Cell Therapeutics,
Inc.

leukemia. 201 Elliott Ave. West

TN= Trisenox Suite 400

Seattle WA 98119

DD= 3/3/98 MA= 9/25/00

Artesunate Treatment of malaria. World Health Organisation

Special Programme for Research

TN= Via Appia , Geneva 27

Switzerland CH

DD= 7/19/99 MA=

As-101 Treatment of acquired NPDC-AS101, Inc.

immunodeficiency syndrome. 783 Jersey Avenue

TN= New Brunswick NJ 08901

DD= 11/9/87 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Atovaquone Treatment and suppression of Glaxo Wellcome Inc.

Toxoplasma gondii encephalitis. 5 Moore Drive

TN= Mepron PO Box 13398

Research Triangle Park NC

DD= 3/16/93 MA=

Atovaquone Primary prophylaxis of HIV-infected Glaxo Wellcome Inc.

persons at high risk for 5 Moore Drive

TN= Mepron developing Toxoplasma gondii PO Box 13398

encephalitis.

Research Triangle Park NC 27709

DD= 3/16/93 MA=

Atovaquone Prevention of Pneumocystis carinii Glaxo Wellcome Research
and

pneumonia (PCP) in high-risk, 5 Moore Drive

TN= Mepron HIV-infected patients defined by a PO Box 13398

history of one or more episodes of

PCP and/or a peripheral CD4+ (T4 Research Triangle Park NC 27709

helper/inducer) lymphocyte count

DD= 8/14/91 MA= 1/5/99

Atovaquone Treatment of AIDS associated Glaxo Wellcome Inc.

Pneumocystis Carinii Pneumonia. 5 Moore Drive

TN= Mepron Research Triangle Park NC 27709

DD= 9/10/90 MA= 11/25/92

Autologous For adjuvant therapy in melanoma Avax Technologies, Inc.

DNP-conjugated tumor patients with surgically resectable 4520 Main St.

TN= M-Vax lymph node metastasis (Stage III Suite 930

and limited Stage IV disease).

Kansas City MO 64111

DD= 2/23/99 MA=

Autolymphocyte therapy Treatment of renal cell carcinoma. Cytogen
Corporation

600 College Road East

TN= CN 5308

Princeton NJ 08540-5308

DD= 7/12/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Azathioprine Treatment of oral manifestations of Oral Solutions, Inc.

graft-versus-host disease. 787 Seventh Ave., 48th Floor

TN= Imuran New York NY 10019

DD= 9/14/99 MA=

B2036-PEG Treatment of acromegaly. Sensus Corporation

Suite 430,

TN= Trovert 98 San Jacinto Boulevard

Austin TX 78701

DD= 6/24/97 MA=

Bacitracin Treatment of antibiotic-associated A. L. Laboratories, Inc.

pseudomembranous enterocolitis One Executive Drive

TN= Altracin caused by toxins A and B elaborated P.O. Box 1399

by Clostridium difficile.

Fort Lee NJ 07024

DD= 3/13/84 MA=

Baclofen Treatment of intractable spasticity Medtronic, Inc.

caused by spinal cord injury, 800 53rd Avenue N.E.

TN= Lioresal Intrathecal multiple sclerosis, and other Minneapolis MN
55432

spinal diseases (including spinal

ischemia, spinal tumor, transverse

myelitis, cervical spondylosis, and

DD= 11/10/87 MA= 6/25/92

Baclofen Treatment of spasticity associated Medtronic, Inc.

with cerebral palsy. 800 53rd Avenue N.E.

TN= Lioresal Intrathecal P.O. 1250

Minneapolis MN 55440-9087

DD= 9/26/94 MA=

Baclofen Treatment of intractable spasticity Infusaid, Inc.

due to multiple sclerosis or 1400 Providence Highway

TN= spinal cord injury. Norwood MA 02062

DD= 12/16/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Basiliximab Prophylaxis of solid organ Novartis Pharmaceuticals

rejection. 59 Route 10

TN= Simulect East Hanover NJ 07936-1080

DD= 12/12/97 MA= 5/12/98

Beclomethasone For oral administration in the George B. McDonald, M.D.

dipropionate treatment of intestinal Fred Hutchinson Cancer Research

TN= graft-versus-host disease. 1100 Fairview Avenue North

Seattle WA 98109

DD= 3/27/98 MA=

Benzoate and For adjunctive therapy in the B. Braun Medical Inc.

phenylacetate prevention and treatment of 2525 McGaw Avenue

TN= Ucephan hyperammonemia in patients with P.O. Box 19791

urea cycle enzymopathy due to

carbamylphosphate synthetase, Irvine CA 92623

ornithine, transcarbamylase, or

DD= 1/21/86 MA= 12/23/87

benzoate/phenylacetate For the treatment of acute Medicis Pharmaceutical
Corp.

hyperammonemia and associated 8125 N. Hayden Road

TN= Ammonul encephalopathy in patients with Scottsdale AZ 85258

deficiencies in enzymes of the urea

cycle.

DD= 11/22/93 MA=

Benzydamine Prophylactic treatment of oral Angelini Pharmaceuticals,
Inc.

hydrochloride mucositis resulting from radiation 70 Grand Avenue

TN= Tantum therapy for head and neck cancer. River Edge NJ 07661

DD= 5/18/98 MA=

Benzylpenicillin, Assessing the risk of Hollister-Stier Laboratories LLC

benzylpenicilloic, administrating penicillin when it PO Box 3145

TN= Pre-Pen/MDM is the preferred drug of choice in Spokane WA 99220-3145

adult patients who have previously

received penicillin and have a

history of clinical sensitivity.

DD= 9/29/87 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Beractant Treatment of full-term newborn Ross Laboratories

infants with respiratory failure 625 Cleveland Avenue

TN= Survanta caused by meconium aspiration Columbus OH 43215

syndrome, persistent pulmonary

hypertension of the newborn, or

pneumonia and sepsis.

DD= 12/20/93 MA=

Beractant Prevention of neonatal respiratory Ross Laboratories

distress syndrome. 625 Cleveland Avenue

TN= Survanta Columbus OH 43215

DD= 2/5/86 MA= 7/1/91

Beractant Treatment of neonatal respiratory Ross Laboratories

distress syndrome. 625 Cleveland Avenue

TN= Survanta Columbus OH 43215

DD= 2/5/86 MA= 7/1/91

Beraprost Treatment of pulmonary arterial United Therapeutics
Corporation

hypertension associated with any 68 T.W. Alexander Drive, PO Box

TN= New York Heart Association Research Triangle Park NC 27709

classification (Class I, II, III,

or IV).

DD= 4/29/99 MA=

Beta alethine Treatment of metastatic melanoma. Dovetail Technologies,
Inc.

Bldg. 337, Paint Branch Drive

TN= Betathine College Park MD 20742

DD= 3/24/97 MA=

Beta alethine Treatment of multiple myeloma. Dovetail Technologies, Inc.

Bldg. 337, Paint Branch Drive

TN= Betathine College Park MD 20742

DD= 3/24/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Betaine Treatment of homocystinuria. Orphan Medical, Inc.

13911 Ridgedale Drive

TN= Cystadane Suite 475

Minnetonka MN 55305

DD= 5/16/94 MA= 10/25/96

Bethanidine sulfate Prevention of recurrence of primary Medco Research,
Inc.

ventricular fibrillation. 8455 Beverly Blvd.

TN= Suite 308

Los Angeles CA 90048

DD= 11/24/89 MA=

Bethanidine sulfate Treatment of primary ventricular Medco Research,
Inc.

fibrillation. 8455 Beverly Blvd.

TN= Suite 308

Los Angeles CA 90048

DD= 9/20/88 MA=

Bexarotene Treatment of cutaneous Ligand Pharmaceuticals, Inc.

manifestations of cutaneous T-cell 10275 Science Center Dr.

TN= Targretin lymphoma in patients who are San Diego CA 92121

refractory to at least one prior

systemic therapy.

DD= 6/18/99 MA= 12/29/99

Bindarit Treatment of lupus nephritis. Angelini Pharmaceuticals, Inc.

70 Grand Avenue

TN= River Edge NJ 07661

DD= 2/3/98 MA=

Bis(4-fluorophenyl)pheny Treatment of sickle cell disease. ICAgen Inc.

lacetamide Ion Channel Advances

TN= PO Box 14487

Durham NC 27709

DD= 3/2/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Bispecific antibody For in vivo serotherapy of patients Medarex, Inc.

520c9x22 with ovarian cancer. 67 Beaver Avenue

TN= Annandale NJ 08801-0953

DD= 10/5/93 MA=

Bleomycin Treatment of pancreatic cancer. Genetronics, Inc.

11199 Sorrento Valley Rd.

TN= Blenoxane San Diego CA 92121-1334

DD= 2/9/99 MA=

Bleomycin sulfate Treatment of malignant pleural Bristol-Myers Squibb

effusion. P.O. Box 4000

TN= Blenoxane Princeton NJ 08543

DD= 9/17/93 MA= 2/20/96

BMY-45622 Treatment of ovarian cancer. Bristol-Myers Squibb

5 Research Parkway

TN= Wallingford CT 06492

DD= 10/15/90 MA=

Bosentan Treatment of pulmonary arterial Actelion Life Sciences Ltd.

hypertension. 1840 Gateway Dr.

TN= 2nd Floor

San Mateo CA 94404

DD= 10/6/00 MA=

Botulinum toxin type A Treatment of blepharospasm Allergan, Inc.

associated with dystonia in adults 2525 Dupont Drive

TN= Botox (patients 12 years of age and P.O. Box 19534

above).

Irvine CA 92713

DD= 3/22/84 MA= 12/29/89

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Botulinum toxin type A Treatment of strabismus associated Allergan, Inc.

with dystonia in adults (patients 2525 Dupont Drive

TN= Botox 12 years of age and above). P.O. Box 19534

Irvine CA 92713

DD= 3/22/84 MA= 12/29/89

Botulinum toxin type A Treatment of essential Porton International, Inc.

blepharospasm. 1155 15th Street, N.W., #315

TN= Dysport Washington DC 20005

DD= 3/23/89 MA=

Botulinum toxin type A Treatment of spasmodic torticollis Ipsen Limited

(cervical dystonia). 1 Bath Road

TN= Dysport Maidenhead, Berkshire

U.K. SL6 4UH GB

DD= 8/12/98 MA=

Botulinum toxin type A Treatment of dynamic muscle Allergan, Inc.

contracture in pediatric cerebral 2525 Dupont Drive

TN= Botox palsy patients. P.O. Box 19534

Irvine CA 92623-9534

DD= 12/6/91 MA=

Botulinum toxin type A Treatment of dynamic muscle Ipsen Limited

contractures in pediatric cerebral 1 Bath Rd., Maidenhead

TN= Dysport palsy patients. Berkshire SL6 4UH

England GB

DD= 10/20/99 MA=

Botulinum toxin type A Treatment of synkinetic closure of Botulinum
Toxin Research

the eyelid associated with VII 1261 Furnace Brook Parkway

TN= cranial nerve aberrant Quincy MA 02169

regeneration.

DD= 9/15/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Botulinum toxin type A Treatment of cervical dystonia. Allergan, Inc.

2525 Dupont Drive

TN= Botox P.O. Box 19534

Irvine CA 92623-9534

DD= 8/20/86 MA= 12/21/00

Botulinum toxin type B Treatment of cervical dystonia. Elan
Pharmaceuticals, Inc.

800 Gateway Blvd.

TN= NeuroBloc South San Francisco CA 94080

DD= 1/16/92 MA= 12/8/00

Botulinum toxin type F Treatment of essential Ipsen Limited (name

blepharospasm.

TN= Dysport Milford MA

DD= 12/5/91 MA=

Botulinum toxin type F Treatment of spasmodic torticollis Ipsen Limited
(name

(cervical dystonia).

TN= Dysport Milford MA

DD= 10/24/91 MA=

Botulism immune globulin Treatment of infant botulism. California
Department of Health

2151 Berkeley Way

TN= Berkeley CA 94704-1011

DD= 1/31/89 MA=

Bovine colostrum Treatment of AIDS-related diarrhea. Hastings, Donald
DVM

1030 North Parkview Drive

TN= Bismarck ND 58501

DD= 11/19/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Bovine immunoglobulin Treatment and symptomatic relief of GalaGen, Inc.

concentrate, Cryptosporidium parvum infection 4001 Lexington Avenue
North

TN= Sporidin-G of the gastrointestinal tract in Arden Hills MN 55126

immunocompromised patients.

DD= 3/1/94 MA=

Bovine whey protein Treatment of cryptosporidiosis Biomune Systems, Inc.

concentrate caused by the presence of 540 Arapeen Drive, Suite 202

TN= Immuno-C Cryptosporidium parvum in the Salt Lake City UT 84108

gastrointestinal tract of patients

who are

immunodeficient/immunocompromised

DD= 9/30/93 MA=

Branched chain amino Treatment of amyotrophic lateral Mount Sinai
Medical Center

acids sclerosis. One Gustave L. Levy Place

TN= New York NY 10029

DD= 12/23/88 MA=

Brimonidine Treatment of anterior ischemic Allergan, Inc.

optic neuropathy. 2525 Dupont Dr.

TN= Alphagan P.O. Box 19534

Irvine CA 92623-9534

DD= 2/7/00 MA=

Bromhexine Treatment of mild to moderate Boehringer Ingelheim

keratoconjunctivitis sicca in 900 Ridgebury Road, Box 368

TN= Bisolvon patients with Sjogren\'s syndrome. Ridgefield CT 06877-0368

DD= 5/15/89 MA=

Broxuridine Radiation sensitizer in the NeoPharm, Inc.

treatment of primary brain tumors. 225 East Deerpath, Suite 250

TN= Broxine/Neomark Lake Forest IL 60045

DD= 9/18/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Buffered intrathecal For use as a diluent in the Orphan Medical, Inc.

electrolyte/dextrose intrathecal administration of 13911 Ridgedale Drive

TN= Elliotts B Solution methotrexate and cytarabine for the Suite 475

prevention or treatment meningeal

leukemia and lymphocytic lymphoma. Minnetonka MN 55305

DD= 8/24/94 MA= 9/27/96

Buprenorphine Treatment of opiate addiction in Reckitt & Colman

hydrochloride opiate users. 1901 Huguenot Road

TN= Subutex Richmond VA 23235

DD= 6/15/94 MA=

Buprenorphine in Treatment of opiate addiction in Reckitt & Colman

combination with opiate users. 1901 Huguenot Road

TN= Suboxone Richmond VA 23235

DD= 10/27/94 MA=

Busulfan For use as preparative therapy for Sparta Pharmaceuticals, Inc.

malignancies treated with bone 111 Rock Road

TN= Spartaject marrow transplantation. Horsham PA 19044-2310

DD= 4/21/94 MA=

Busulfan As preparative therapy in the Orphan Medical, Inc.

treatment of malignancies with bone 13911 Ridgedale Drive

TN= Busulfex marrow transplantation. Suite 250

Minnetonka MN 55305

DD= 7/28/94 MA= 2/4/99

Busulfan Treatment of primary brain SuperGen, Inc.

malignancies. Two Annabel Lane, Suite 220

TN= Spartaject San Ramon CA 94583

DD= 7/7/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Butyrylcholinesterase For the reduction and clearance of Shire
Laboratories Inc.

toxic blood levels of cocaine 1550 East Gude Drive

TN= encountered during a drug overdose. Rockville MD 20850

DD= 3/25/92 MA=

Butyrylcholinesterase Treatment of post-surgical apnea. Shire
Laboratories Inc.

1550 East Gude Drive

TN= Rockville MD 20850

DD= 9/30/92 MA=

BW 12C Treatment of sickle cell disease. Burroughs Wellcome Company

3030 Cornwallis Road

TN= P.O. Box 12700

Research Triangle Pk NC 27709

DD= 10/23/87 MA=

C1 esterase inhibitor Treatment and prevention of Alpha Therapeutic
Corporation

(human) angioedema caused by C1-esterase 5555 Valley Boulevard

TN= inhibitor deficiency. Los Angeles CA 90032

DD= 8/21/96 MA=

C1-esterase-inhibitor, Prevention and/or treatment of Aventis Behring
L.L.C.

human, pasteurized acute attacks of hereditary 1020 First Ave.

TN= Berinert P angioedema. PO Box 61501

King of Prussia PA 19406-0901

DD= 10/16/92 MA=

C1-inhibitor Prevention of acute attacks of Baxter Healthcare Corp.

angioedema, including short-term Hyland Division (Baxter Hyland)

TN= C1-inhibitor (human) prophylaxis for patients requiring 550 North
Brand Blvd.

dental or other surgical

procedures. Glendale CA 91203

DD= 8/30/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

C1-inhibitor Treatment of acute attacks of Baxter Healthcare Corp.

angioedema. Hyland Division (Baxter Hyland)

TN= C1-inhibitor (human) 550 North Brand Blvd.

Glendale CA 91203

DD= 8/30/90 MA=

Caffeine Treatment of apnea of prematurity. O.P.R. Development, L.P.

1501 Wakarusa Drive

TN= Cafcit Lawrence KS 66047

DD= 9/20/88 MA= 9/21/99

Calcitonin salmon nasal Treatment of symptomatic Paget\'s Sandoz
Pharmaceuticals Corp.

spray disease (osteitis deformans). 59 Route 10

TN= Miacalcin Nasal East Hanover NJ 07936

DD= 10/29/90 MA=

Calcitonin-human for Treatment of symptomatic Paget\'s Novartis
Pharmaceutical

injection disease (osteitis deformans). 59 Route 10

TN= Cibacalcin East Hanover NJ 07936

DD= 1/20/87 MA= 10/31/86

Calcium acetate Treatment of hyperphosphatemia in Braintree Laboratories

end stage renal failure. 60 Columbian Street

TN= Phos-Lo P.O. Box 361

Braintree MA 02184

DD= 12/22/88 MA= 12/10/90

Calcium acetate Treatment of hyperphosphatemia in Pharmedic Company

end stage renal disease. 28101 Ballard Road, Suite F

TN= Lake Forest IL 60045

DD= 6/27/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Calcium carbonate Treatment of hyperphosphatemia in R & D Laboratories,
Inc.

patients with end stage renal 4204 Glencoe Avenue

TN= R & D calcium disease. Marina Del Rey CA 90292

DD= 6/6/90 MA=

Calcium gluconate For use as a wash for hydrofluoric Calgonate Corp.

acid spills on human skin. 190 Commerce Drive

TN= Calgonate Warwick RI 02886

DD= 11/20/97 MA=

Calcium gluconate gel For use in the emergency topical LTR
Pharmaceuticals, Inc.

treatment of hydrogen fluoride 145 Sakonnet Blvd.

TN= H-F Gel (hydrofluoric acid) burns. Narragansett RI 02882

DD= 5/21/91 MA=

Calcium gluconate gel Emergency topical treatment of Paddock
Laboratories, Inc.

2.5% hydrogen fluoride (hydrofluoric 3940 Quebec Avenue North

TN= acid) burns. Minneapolis MN 55427

DD= 9/10/90 MA=

Calfactant Acute respiratory distress syndrome ONY, Inc.

(ARDS) Baird Research Park

TN= Infasurf 1576 Sweet Home Road

Amherst NY 14228

DD= 9/5/00 MA=

Carbamylglutamic acid Treatment of N-acetylglutamate Orphan Europe

synthetase deficiency. Immeuble \"Le Guillaumet\"

TN= 60, avenue du General de Gaulle

92046 Paris La Defense FR

DD= 1/20/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Carbovir Treatment of persons with AIDS and Glaxo Wellcome Inc.

in patients with symptomatic HIV 5 Moore Drive

TN= infection and a CD4 count less than Research Triangle Park NC 27709

200/mm3.

DD= 12/13/89 MA=

Carmustine Treatment of intracranial Direct Therapeutics, Inc.

malignancies. 1001 Bayhill Dr., Suite 100

TN= San Bruno CA 94066

DD= 7/3/00 MA=

Cascara sagrada fluid Treatment of oral drug overdosage Intramed
Corporation

extract to speed lower bowel evacuation. 102 Tremont Way

TN= Augusta GA 30907

DD= 3/21/89 MA=

CD4 human truncated 369 Treatment of acquired SmithKline Beecham

AA polypeptide immunodeficiency syndrome. Route 23 & Woodmont Ave., P.O.

TN= Soluble T4 King Of Prussia PA 19406

DD= 11/21/89 MA=

CD5-T lymphocyte Treatment of graft versus host Xoma Corporation

immunotoxin disease and/or rejection in 2910 Seventh Street

TN= Xomazyme-H65 patients who have received bone Berkeley CA 94710

marrow transplants.

DD= 8/27/87 MA=

CDP571 Treatment of Crohn\'s disease. Celltech Chiroscience Limited

216 Bath Road

TN= Slough SL1 4EN

Berkshire UK

DD= 12/11/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Centruroides immune Treatment of scorpion envenomations Silanes
Laboratories S.A. de

F(ab)2 requiring medical attention. Amores #1034 Col Del Valle

TN= Alacramyn C.P. 03100 Mexico D.F.

DD= 6/12/00 MA=

Ceramide Treatment of Fabry\'s disease. Genzyme Corporation

trihexosidase/alpha-gala One Kendall Square

TN= Cambridge MA 02139-1562

DD= 1/19/88 MA=

Cetiedil citrate Treatment of sickle cell disease Baker Cummins
Pharmaceuticals,

injection crisis.

TN=

DD= 12/22/88 MA=

Cetuximab Treatment of squamous cell cancer ImClone Systems Incorporated

of the head and neck in patients Branchburg Corporate Center

TN= who express epidermal growth factor 22 Chubb Way

receptor.

Somerville NJ 08876

DD= 7/3/00 MA=

Chenodiol For patients with radiolucent Solvay

stones in well opacifying 901 Sawyer Road

TN= Chenix gallbladders, in whom elective Marietta GA 30062

surgery would be undertaken except

for the presence of increased

surgical risk due to systemic

DD= 9/21/84 MA= 7/28/83

Chimeric (human-murine) Treatment of renal cell carcinoma. Wilex
Biotechnology GmbH

G250 IgG monoclonal Grillparzerstrasse 10B

TN= 81675 Munich

Germany DE

DD= 7/24/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Chimeric M-T412 Treatment of multiple sclerosis. Centocor, Inc.

(human-murine) IgG 244 Great Valley Parkway

TN= Malvern PA 19355

DD= 6/5/91 MA=

Chimeric, humanized Prophylaxis of Staphylococcus Biosynexus, Inc.

monoclonal antibody to epidermidis sepsis in low birth 9610 Medical
Center Drive

TN= weight (1500 grams or less) Suite 100

infants.

Rockville MD 20850

DD= 8/3/00 MA=

Chlorhexidine gluconate For use in the amelioration of oral Procter &
Gamble Company

mouthrinse mucositis associated with Sharon Wood Technical Center

TN= Peridex cytoreductive therapy used in 11370 Reed Hartman Highway

conditioning patients for bone

marrow transplantation therapy. Cincinnati OH 45241

DD= 8/18/86 MA=

Choline chloride Treatment of choline deficiency, Orphan Medical, Inc.

specifically the choline 13911 Ridgedale Drive

TN= Intrachol deficiency, hepatic steatosis, and Suite 250

cholestasis, associated with

long-term parenteral nutrition. Minnetonka MN 55305

DD= 2/10/94 MA=

Chondrocyte-alginate gel For use in correcting Curis, Inc.

suspension vesicoureteral reflux in the 61 Moulton Street

TN= pediatric population. Cambridge MA 02138

DD= 12/1/97 MA=

Chondroitinase Treatment of patients undergoing Bausch & Lomb
Pharmaceuticals,

vitrectomy. 8500 Hidden River Pkwy.

TN= Tampa FL 33637

DD= 2/9/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ciliary neurotrophic Treatment of amyotrophic lateral Regeneron
Pharmaceuticals Inc

factor sclerosis. 777 Old Saw Mill River Road

TN= Tarrytown NY 10591

DD= 1/30/92 MA=

Ciliary neurotrophic Treatment of motor neuron disease Syntex-Synergen
Neuroscience

factor, recombinant (including amyotrophic lateral 3200 Walnut Street

TN= sclerosis, progressive muscular Boulder CO 80301

atrophy, progressive bulbar palsy,

and primary lateral sclerosis).

DD= 5/8/92 MA=

Ciliary neurotrophic Treatment of spinal muscular Syntex-Synergen
Neuroscience

factor, recombinant atrophies. 3200 Walnut Street

TN= Boulder CO 80301

DD= 4/2/92 MA=

Cisplatin/epinephrine Treatment of squamous cell Matrix Pharmaceutical,
Inc.

carcinoma of the head and neck. 34700 Campus Drive

TN= IntraDose Fremont CA 94555-3612

DD= 4/3/00 MA=

Cisplatin/epinephrine Treatment of metastatic malignant Matrix
Pharmaceutical, Inc.

melanoma. 34700 Campus Drive

TN= IntraDose Fremont CA 94555-3612

DD= 9/7/00 MA=

Citric acid, Treatment of renal and bladder United-Guardian, Inc.

glucono-delta-lactone calculi of the apatite or struvite P.O. Box 2500

TN= Renacidin Irrigation variety. Smithtown NY 11787

DD= 8/28/89 MA= 10/2/90

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Cladribine Treatment of non-Hodgkin\'s R. W. Johnson Pharmaceutical

lymphoma. Route 202 South, P.O. Box 300

TN= Leustatin Injection Raritan NJ 08869-0602

DD= 4/19/93 MA=

Cladribine Treatment of chronic lymphocytic R. W. Johnson Pharmaceutical

leukemia. Route 202, P.O. Box 300

TN= Leustatin Injection Raritan NJ 08869-0602

DD= 12/31/90 MA=

Cladribine Treatment of the chronic R. W. Johnson Pharmaceutical

progressive form of multiple Route 202

TN= Mylinax sclerosis. PO Box 300

Raritan NJ 08869-0602

DD= 4/19/94 MA=

Cladribine Treatment of hairy cell leukemia. R. W. Johnson
Pharmaceutical

Route 202, P.O. Box 300

TN= Leustatin Injection Raritan NJ 08869

DD= 11/15/90 MA= 2/26/93

Cladribine Treatment of acute myeloid R. W. Johnson Pharmaceutical

leukemia. Route 202

TN= Leustatin P.O. Box 300

Raritan NJ 08869

DD= 7/20/90 MA=

Clindamycin Prevention of Pneumocystis carinii Pharmacia & Upjohn

pneumonia in AIDS patients. 7000 Portage Road

TN= Cleocin Unit 0633-298-113

Kalamazoo MI 49001-0199

DD= 10/28/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Clindamycin Treatment of Pneumocystis carinii Pharmacia & Upjohn

pneumonia associated with AIDS 7000 Portage Road

TN= Cleocin patients. Unit 0633-298-113

Kalamazoo MI 49001-0199

DD= 10/28/88 MA=

Clofazimine Treatment of lepromatous leprosy, Novartis Pharmaceutical

including dapsone-resistant 59 Route 10

TN= Lamprene lepromatous leprosy and lepromatous East Hanover NJ 07936

leprosy complicated by erythema

nodosum leprosum.

DD= 6/11/84 MA= 12/15/86

Clonazepam Treatment of hyperekplexia (startle Hoffmann-La Roche, Inc.

disease). 340 Kingsland Street

TN= Klonopin Nutley NJ 07110

DD= 8/4/94 MA=

Clonidine For continous epidural Roxane Laboratories, Inc.

administration as adjunctive PO Box 16532

TN= Duraclon therapy with intraspinal opiates Columbus OH 43216-6532

for the treatment of pain in cancer

patients tolerant to, or

unresponsive to, intraspinal

DD= 1/24/89 MA= 10/2/96

Clostridial collagenase Treatment of advanced (involutional Hurst, L.
M.D. & Badalamente, M.

or residual stage) Dupuytren\'s State University of New York at

TN= disease. School of Medicine, Health

Stony Brook NY 11794-8181

DD= 5/23/96 MA=

Clotrimazole Treatment of sickle cell disease. Brugnara, Carlo M.D.

The Children\'s Hospital

TN= 300 Longwood Avenue, Bader 760

Boston MA 02115

DD= 4/24/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Coagulation factor IX Replacement treatment and Armour Pharmaceutical
Company

prophylaxis of the hemorrhagic 500 Arcola Road, P.O. Box 1200

TN= Mononine complications of hemophilia B. Collegeville PA 19426

DD= 6/27/89 MA= 8/20/92

Coagulation Factor IX For use as replacement therapy in Alpha
Therapeutic Corporation

(human) patients with hemophilia B for the 5555 Valley Boulevard

TN= AlphaNine prevention and control of bleeding Los Angeles CA 90032

episodes, and during surgery to

correct defective hemostasis.

DD= 7/5/90 MA= 12/31/90

Coagulation Factor IX Treatment of hemophilia B. Genetics Institute,
Inc.

(recombinant) 87 Cambridge Park Drive

TN= BeneFix Cambridge MA 02140

DD= 10/3/94 MA= 2/11/97

Coagulation factor VIIa Treatment of bleeding episodes in Novo Nordisk
Pharmaceuticals,

(recombinant) hemophilia A or B patients with 100 Overlook Center

TN= NovoSeven inhibitors to Factor VIII or Factor Suite 200

IX\.

Princeton NJ 08540-7810

DD= 6/6/88 MA= 3/25/99

Colchicine For arresting the progression of Pharmacontrol Corporation

neurologic disability caused by 661 Palisade Ave., P.O. Box 931

TN= chronic progressive multiple Englewood Cliffs NJ 07632

sclerosis.

DD= 12/9/85 MA=

Colfosceril palmitate, Treatment of established hyaline Glaxo Wellcome
Inc.

cetyl alcohol, tyloxapol membrane disease at all gestational 5 Moore
Drive

TN= Exosurf Neonatal for ages. Research Triangle Park NC 27709

DD= 10/20/89 MA= 8/2/90

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Colfosceril palmitate, Prevention of hyaline membrane Glaxo Wellcome
Inc.

cetyl alcohol, tyloxapol disease, also known as respiratory 5 Moore
Drive

TN= Exosurf Neonatal for distress syndrome, in infants born Research
Triangle Park NC 27709

at 32 weeks gestation or less.

DD= 10/20/89 MA= 8/2/90

Colfosceril palmitate, Treatment of adult respiratory Glaxo Wellcome
Research and

cetyl alcohol, tyloxapol distress syndrome. 5 Moore Drive

TN= Exosurf P.O. Box 13398

Research Triangle Park NC 27709

DD= 1/11/93 MA=

Collagenase Treatment of Peyronie\'s disease. Advance Biofactures
Corporation

(lyophilized) for 35 Wilbur Street

TN= Plaquase Lynbrook NY 11563-2358

DD= 3/12/96 MA=

Corticorelin ovine For use in differentiating Ferring Laboratories, Inc.

triflutate pituitary and ectopic production of 400 Rella Boulevard,
Suite 201

TN= Acthrel ACTH in patients with Suffern NY 10901

ACTH-dependent Cushings syndrome.

DD= 11/24/89 MA= 5/23/96

Corticotropin-releasing Treatment of peritumoral brain Neurobiological
Technologies,

factor, human edema. 1387 Marina Way South

TN= Xerecept Richmond CA 94804

DD= 4/6/98 MA=

Coumarin Treatment of renal cell carcinoma. Drossapharm LTD

4002 Basel

TN= Onkolox Switzerland CH

DD= 12/22/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Cromolyn sodium Treatment of mastocytosis. Fisons Corporation

755 Jefferson Rd

TN= Gastrocrom P.O. Box 1710

Rochester NY 14603

DD= 3/8/84 MA= 12/22/89

Cromolyn sodium 4% Treatment of vernal Fisons Corporation

ophthalmic solution keratoconjunctivitis. 755 Jefferson Rd.

TN= Opticrom 4% P.O. Box 1710

Rochester NY 14603

DD= 7/24/85 MA= 10/3/84

Cryptosporidium Treatment of diarrhea in AIDS ImmuCell Corporation

hyperimmune bovine patients caused by infection with 56 Evergreen Drive

TN= Cryptosporidium parvum. Portland ME 04103

DD= 12/30/91 MA=

CT-2584 mesylate Treatment of adult soft tissue Cell Therapeutics, Inc.

sarcoma. 201 Elliott Ave. West

TN= Suite 400

Seattle WA 98119

DD= 4/16/99 MA=

CT-2584 mesylate Treatment of malignant Cell Therapeutics, Inc.

mesothelioma. 201 Elliott Ave. West

TN= Seattle WA 98119

DD= 4/16/99 MA=

CY-1503 Treatment of post-ischemic Cytel Corporation

pulmonary reperfusion edema 3525 John Hopkins Court

TN= Cylexin following surgical treatment for San Diego CA 92121

chronic thromboembolic pulmonary

hypertension.

DD= 12/22/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

CY-1503 Treatment of neonates and infants Cytel Corporation

undergoing cardiopulmonary bypass 3525 John Hopkins Court

TN= Cylexin during surgical repair of San Diego CA 92121

congenital heart lesions.

DD= 7/18/97 MA=

CY-1899 Treatment of chronic active Cytel Corporation

hepatitis B infection in HLA-A2 3525 John Hopkins Court

TN= positive patients. San Diego CA 92121

DD= 3/16/94 MA=

Cyclosporine 2% For use in corneal melting Allergan, Inc.

ophthalmic ointment syndromes of known or presumed 2525 Dupont Drive

TN= immunologic etiopathogenesis, P.O. Box 19534

including Mooren\'s ulcer.

Irvine CA 92623-9534

DD= 8/1/91 MA=

Cyclosporine 2% Treatment of patients at high risk Allergan, Inc.

ophthalmic ointment of graft rejection following 2525 Dupont Drive

TN= penetrating keratoplasty. P.O. Box 19534

Irvine CA 92623-9534

DD= 8/1/91 MA=

Cyclosporine in Prevention of solid organ graft RTP Pharma Corporation

combination with omega-3 rejection. 200 Westpark Corporate Center

TN= 4364 South Alston Avenue

Durham NC 27713-2280

DD= 12/6/00 MA=

Cyclosporine ophthalmic Treatment of severe University Of Georgia

keratoconjunctivitis sicca College Of Veterinary Medicine

TN= Optimmune associated with Sjogren\'s syndrome. Department of Small
Animal

Athens GA 30602

DD= 11/9/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Cyproterone acetate Treatment of severe hirsutism. \\

300 Fairfield Road

TN= Androcur Wayne NJ 07470

DD= 10/26/84 MA=

Cysteamine Treatment of nephropathic Mylan Laboratories, Inc.

cystinosis. 781 Chestnut Ridge Road

TN= Cystagon P.O. Box 4310

Morgantown WV 26504

DD= 1/25/91 MA= 8/15/94

Cysteamine Treatment of nephropathic Thoene, Jess G., M.D.

cystinosis. University of Michigan Medical

TN= 300 NIB, 1192 SE

Ann Arbor MI 48109-0408

DD= 5/1/86 MA=

Cysteamine hydrochloride Treatment of corneal cystine Sigma-Tau
Pharmaceuticals, Inc.

crystal accumulation in cystinosis 800 South Frederick Avenue

TN= patients. Gaithersburg MD 20877

DD= 8/19/97 MA=

Cystic fibrosis gene Treatment of cystic fibrosis. Genzyme Corporation

therapy One Mountain Rd.

TN= P.O. Box 9322

Framingham MA 01701-9322

DD= 6/30/92 MA=

Cystic fibrosis Tr gene Treatment of cystic fibrosis. GenVec, Inc.

therapy (recombinant 12111 Parklawn Drive

TN= AdGVCFTR.10 Rockville MD 20852

DD= 3/9/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Cystic fibrosis For cystic fibrosis transmembrane Genzyme Corporation

transmembrane conductance regulator protein One Mountain Road

TN= replacement therapy in cystic P.O. Box 9322

fibrosis patients.

Framingham MA 01701-9322

DD= 1/14/92 MA=

Cystic fibrosis Treatment of cystic fibrosis. Genetic Therapy, Inc.

transmembrane 938 Clopper Road

TN= Gaithersburg MD 20878

DD= 1/8/93 MA=

Cytarabine liposomal Treatment of neoplastic meningitis. DepoTech
Corporation

10450 Science Center Drive

TN= DepoCyt San Diego CA 92121

DD= 6/2/93 MA= 4/1/99

Cytomegalovirus immune Prevention or attenuation of Massachussetts
Public Health

globulin (human) primary cytomegalovirus disease in 305 South Street

TN= CytoGam immunosuppressed recipients of Boston MA 02130-3597

organ transplants.

DD= 8/3/87 MA= 12/4/98

Cytomegalovirus immune For use in conjunction with Bayer Corporation

globulin intravenous ganciclovir sodium for the Pharmaceutical Division,

TN= treatment of cytomegalovirus 400 Morgan Lane

pneumonia in bone marrow transplant

patients. New Haven CT 06516

DD= 1/28/91 MA=

Daclizumab Prevention of acute renal allograft Hoffmann-La Roche, Inc.

rejection. 340 Kingsland Street

TN= Zenapax Nutley NJ 07110

DD= 3/5/93 MA= 12/10/97

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Dantrolene sodium Treatment of the neuroleptic Norwich Eaton
Pharmaceuticals

malignant syndrome. P.O. Box 191

TN= Dantrium Norwich NY 13815

DD= 12/14/87 MA=

Dapsone Prophylaxis of toxoplasmosis in Jacobus Pharmaceutical Company,

severely immunocompromised patients 37 Cleveland Lane

TN= with CD4 counts below 100. P.O. Box 5290

Princeton NJ 08540

DD= 11/7/94 MA=

Dapsone USP Prophylaxis for Pneumocystis Jacobus Pharmaceutical Company

carinii pneumonia. 37 Cleveland Lane

TN= Dapsone P.O. Box 5290

Princeton NJ 08540

DD= 12/24/91 MA=

Dapsone USP For the combination treatment of Jacobus Pharmaceutical
Company

Pneumocystis carinii pneumonia in 37 Cleveland Lane

TN= Dapsone conjunction with trimethoprim. P.O. Box 5290

Princeton NJ 08540

DD= 1/8/92 MA=

Daunorubicin citrate Treatment of patients with advanced NeXstar
Pharmaceuticals, Inc.

liposome injection HIV-associated Kaposi\'s sarcoma. 650 Cliffside Drive

TN= DaunoXome San Dimas CA 91773

DD= 5/14/93 MA= 4/8/96

Decitabine Treatment of chronic myelogenous Pharmachemie B.V.

leukemia. Swensweg 5

TN= 2031 GA Haarlem

The Netherlands NL

DD= 3/8/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Decitabine Treatment of myelodysplastic SuperGen, Inc.

syndromes. Two Annabel Lane, Suite 220

TN= San Ramon CA 94583

DD= 3/8/99 MA=

Defibrotide Treatment of thrombotic Crinos International

thrombocytopenic purpura. Via Belvedere 1

TN= Villa Guardia, Italy 22079

DD= 7/5/85 MA=

Dehydroepiandrosterone Treatment of systemic lupus Genelabs
Technologies, Inc.

erythematosus (SLE) and the 505 Penobscot Drive

TN= reduction in the use of steroids in Redwood City CA 94063

steroid-dependent SLE patients.

DD= 7/13/94 MA=

Dehydroepiandrosterone Treatment of serious burns Pharmadigm, Inc.

sulfate sodium requiring hospitalization. 2401 Foothill Drive

TN= Salt Lake City UT 84109-1405

DD= 1/29/97 MA=

Dehydroepiandrosterone To accelerate the Pharmadigm, Inc.

sulfate sodium re-epithelialization of donor sites 2401 Foothill Drive

TN= in those hospitalized burn Salt Lake City UT 84109-1405

patients who must undergo

autologous skin grafting.

DD= 1/28/97 MA=

Denileukin diftitox Treatment of patients with Seragen, Inc.

persistent or recurrent cutaneous 97 South Street

TN= Ontak T-cell lymphoma whose malignant Hopkinton MA 01748

cells express the CD25 component of

the IL-2 receptor.

DD= 8/21/96 MA= 2/5/99

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Deoxyribose, Treatment of advanced malignant Genta, Inc.

phosphorothioate melanoma (Stages II,III, IV). 99 Hayden Ave., Suite 200

TN= Lexington MA 02421-7966

DD= 7/31/00 MA=

Deslorelin Treatment of central precocious Roberts Pharmaceutical Corp.

puberty. Meridian Center II

TN= Somagard Four Industrial Way West

Eatontown NJ 07724-2274

DD= 11/5/87 MA=

Desmopressin acetate Treatment of mild hemophilia A and Aventis Behring
L.L.C.

von Willebrand\'s disease. 1020 First Avenue

TN= PO Box 61501

King of Prussia PA 19406-0901

DD= 1/22/91 MA= 3/7/94

Dexamethasone For use in posterior segment drug Oculex Pharmaceuticals,
Inc.

delivery system in the treatment of 639 N. Pastoria Avenue

TN= idiopathic intermediate uveitis. Sunnyvale CA 94086-2917

DD= 9/11/98 MA=

Dexrazoxane For the prevention of Pharmacia & Upjohn

cardiomyopathy associated with 7000 Portage Road

TN= Zinecard doxorubicin administration. Kalamazoo MI 49001-0199

DD= 12/17/91 MA= 5/26/95

Dextran 70 Treatment of recurrent corneal Holles Laboratories, Inc.

erosion unresponsive to 30 Forest Notch

TN= Dehydrex conventional therapy. Cohasset MA 02025

DD= 3/5/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Dextran and deferoxamine Treatment of acute iron poisoning. Biomedical
Frontiers, Inc.

1095 10th Avenue S.E.

TN= Bio-Rescue Minneapolis MN 55414

DD= 3/8/91 MA=

Dextran sulfate For use as an adjunct to the Kennedy & Hoidal, M.D.\'s

(inhaled, aerosolized) treatment of cystic fibrosis. University Of Utah
Medical

TN= Uendex 50 North Medical Drive, Room

Salt Lake City UT 84132

DD= 10/5/90 MA=

Dextran sulfate sodium Treatment of aquired Ueno Fine Chemicals
Industry,

immunodeficiency syndrome. 2-31 Koraibashi, Higashi-ku

TN= Osaka 541, Japan

DD= 11/19/87 MA=

Dianeal peritoneal For use as a nutritional supplement Baxter Healthcare
Corporation

dialysis solution with for the treatment of 1620 Waukegan Road

TN= Nutrineal malnourishment in patients McGaw Park IL 60085

undergoing continuous ambulatory

peritoneal dialysis.

DD= 6/11/92 MA=

Diazepam viscous For the management of selected, Athena Neurosciences,
Inc.

solution for rectal refractory, patients with epilepsy, 800f Gateway
Boulevard

TN= on stable regimens of South San Francisco CA 94080

antiepileptic drugs (AEDs), who

require intermittent use of

diazepam to control bouts of

DD= 2/25/92 MA= 7/29/97

Diaziquone Treatment of primary brain Warner-Lambert Company

malignancies (grade III and IV 2800 Plymouth Rd., P.O. Box 1047

TN= astrocytomas). Ann Arbor MI 48106

DD= 11/10/83 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Dideoxyinosine Treatment of acquired Bristol-Myers Squibb

immunodeficiency syndrome.

TN=

DD= 6/22/88 MA=

Diethyldithiocarbamate Treatment of AIDS. Connaught Laboratories

Route 611, P.O. Box 187

TN= Imuthiol Swiftwater PA 18370

DD= 4/3/86 MA=

Digoxin immune FAB Treatment of potentially life Glaxo Wellcome Inc.

(Ovine) threatening digitalis intoxication 5 Moore Drive

TN= Digibind in patients who are refractory to Research Triangle Park NC
27709

management by conventional therapy.

DD= 11/1/84 MA= 4/22/86

Digoxin immune Treatment of life-threatening acute Boehringer Mannheim
Corp.

fab(ovine) cardiac glycoside intoxication 1301 Piccard Drive

TN= Digidote manifested by conduction disorders, Rockville MD 20850

ectopic ventricular activity and

(in some cases) hyperkalemia.

DD= 3/11/85 MA=

Dihydrotestosterone Treatment of weight loss in AIDS Unimed
Pharmaceuticals, Inc.

patients with HIV-associated Four Parkway North

TN= Androgel -DHT wasting. Deerfield IL 60015-2544

DD= 2/5/96 MA=

Dimethyl sulfoxide Treatment of cutaneous Research Industries Corp.

manifestations of scleroderma.

TN=

DD= 6/6/86 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Dimethyl sulfoxide Treatment of increased intracranial Pharma 21

pressure in patients with severe, c/o Univ. of Calif., San Diego

TN= closed-head injury, also known as 9500 Gilman Dr.

traumatic brain coma, for whom no

other effective treatment is La Jolla CA 92093-0624

available.

DD= 11/22/94 MA=

Dimethylsulfoxide Treatment of palmar-plantar Cancer Technologies, Inc.

erythrodysethesia syndrome. 7301 East 22nd Street

TN= Suite 10E

Tucson AZ 85710

DD= 4/6/98 MA=

Dimethylsulfoxide Topical treatment for the Cancer Technologies, Inc.

prevention of soft tissue injury 7301 East 22nd Street

TN= following extravastion of cytotoxic Suite 10E

drugs.

Tucson AZ 85710

DD= 4/15/97 MA=

Dipalmitoylphosphatidylc Prevention and treatment of Forum Products,
Inc.

holine neonatal respiratory distress 33 Flying Point Road

TN= ALEC syndrome. Southampton NY 11968

DD= 7/28/88 MA=

Disaccharide tripeptide Treatment of pulmonary and hepatic
ImmunoTherapeutics, Inc.

glycerol dipalmitoyl metastases in patients with 3505 Riverview Circle

TN= Immther colorectal adenocarcinoma. Moorhead MN 56560

DD= 3/1/90 MA=

Disodium clodronate Treatment of hypercalcemia of Discovery Experimental
&

malignancy. 29949 S.R. 54 West

TN= Wesley Chapel FL 33543

DD= 6/16/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Disodium clodronate Treatment of increased bone Anthra Pharmaceuticals,
Inc.

tetrahydrate resorption due to malignancy. 103 Carnegie Center, Suite
102

TN= Bonefos Princeton NJ 08540

DD= 3/5/90 MA=

Disodium silibinin Treatment of hepatic intoxication Pharmaquest
Corporation

dihemisuccinate by Amanita phalloides (mushroom 4470 Redwood Highway

TN= Legalon poisoning). San Rafael CA 94903

DD= 7/10/86 MA=

DMP 777 Therapeutic management of patients DuPont Pharmaceuticals
Company

with lung disease attributable to Chestnut Run, Maple Run

TN= cystic fibrosis. Centre Rd.

Wilmington DE 19805

DD= 6/4/96 MA=

DNA-lipid complex Treatment of renal cell carcinoma. Vical Incorporated

(DMRIE/DOPE)/plasmid 9373 Towne Center Dr.

TN= Leuvectin Suite 100

San Diego CA 92121-3088

DD= 4/28/00 MA=

DNP-Modified autologous Adjuvant therapy for the treatment AVAX
Technologies, Inc.

tumor vaccine of ovarian cancer 4520 Main Street

TN= O-Vax Suite 930

Kansas City MO 64111

DD= 9/21/00 MA=

Dornase alfa To reduce mucous viscosity and Genentech, Inc.

enable the clearance of airway 460 Point San Bruno Boulevard

TN= Pulmozyme secretions in patients with cystic South San Francisco CA
94080

fibrosis.

DD= 1/16/91 MA= 12/30/93

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Doxorubicin liposome Treatment of ovarian cancer. Alza Corporation

1550 Plymouth St.

TN= Doxil PO Box 7210

Mountain View CA 94039-7210

DD= 11/4/98 MA= 6/28/99

Dronabinol For the stimulation of appetite and Unimed Pharmaceuticals,
Inc.

prevention of weight loss in 2150 East Lake Cook Road, Suite

TN= Marinol patients with a confirmed diagnosis Buffalo Grove IL
60089-1862

of AIDS.

DD= 1/15/91 MA= 12/22/92

Duramycin Treatment of cystic fibrosis. MoliChem Medicines Inc.

207 South Elliott Road PMB#231

TN= Chapel Hill NC 27514

DD= 12/11/97 MA=

Dynamine Treatment of Lambert Eaton Mayo Foundation

myasthenic syndrome. 200 First Street Southwest

TN= Rochester MN 55905

DD= 2/5/90 MA=

Dynamine Treatment of hereditary motor and Mayo Foundation

sensory neuropathy type I 200 First Street Southwest

TN= (Charcot-Marie-Tooth disease). Rochester MN 55905

DD= 10/16/91 MA=

Eflornithine HCl Treatment of Pneumocystis carinii Marion Merrell Dow,
Inc.

pneumonia in AIDS patients. P.O. Box 9627

TN= Ornidyl Kansas City MO 64134

DD= 4/18/86 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Eflornithine HCl Treatment of Trypanosoma brucei Hoechst Marion Roussel

gambiense infection (sleeping P.O. Box 9627

TN= Ornidyl sickness). Kansas City MO 64134

DD= 4/23/86 MA= 11/28/90

Elcatonin Intrathecal treatment of Innapharma, Inc.

intractable pain. 10 Mountainview Road

TN= Upper Saddle River NJ 07458

DD= 9/25/95 MA=

Enadoline hydrochloride Treatment of severe head injury. Warner-Lambert
Company

Parke-Davis Pharmaceutical

TN= 2800 Plymouth Road

Ann Arbor MI 48105

DD= 1/28/97 MA=

Encapsulated porcine Treatment of type I diabetic VivoRx

islet preparation patients who are already on 2825 Santa Monica Blvd.

TN= BetaRx immunosuppression. 2nd Floor

Santa Monica CA 90404-2429

DD= 7/5/95 MA=

Enisoprost For use with cyclosporine in organ G.D. Searle & Company

transplant recipients to reduce 4901 Searle Parkway

TN= acute transplant rejection. Skokie IL 60077

DD= 10/20/89 MA=

Enisoprost For use in organ transplant G.D. Searle & Company

patients to diminish the 4901 Searle Parkway

TN= nephrotoxicity induced by Skokie IL 60077

cyclosporine.

DD= 10/20/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Epidermal growth factor For promotion of cutaneous wound Ethicon, Inc.

(human) healing in extreme burn treatment P.O. Box 151

TN= protocols. Somerville NJ 08876

DD= 3/6/85 MA=

Epidermal growth factor For acceleration of corneal Chiron Vision

(human) epithelial regeneration and the 500 Iolab Drive

TN= healing of stromal tissue in the Claremont CA 91711

condition of non-healing corneal

defects.

DD= 10/5/87 MA=

Epirubicin Treatment of breast cancer. Pharmacia & Upjohn Company

0634-298-113

TN= Ellence 7000 Portage Rd.

Kalamazoo MI 49001-0199

DD= 9/14/99 MA= 9/15/99

Epoetin alfa Treatment of anemia associated with Amgen, Inc.

HIV infection or HIV treatment. 1840 Dehavilland Drive

TN= Epogen Thousand Oaks CA 91320

DD= 7/1/91 MA= 12/31/90

Epoetin alfa Treatment of myelodysplastic R. W. Johnson Pharmaceutical

syndrome. Route 202, P.O. Box 300

TN= Raritan NJ 08869-0602

DD= 12/20/93 MA=

Epoetin alfa Treatment of anemia associated with Amgen, Inc.

end stage renal disease. 1840 Dehavilland Drive

TN= Epogen Thousand Oaks CA 91320

DD= 4/10/86 MA= 6/1/89

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Epoetin alpha Treatment of anemia associated with R. W. Johnson
Pharmaceutical

end stage renal disease. Route 202 South

TN= Procrit P.O. Box 300

Raritan NJ 08869

DD= 8/27/87 MA=

Epoetin alpha Treatment of anemia of prematurity R. W. Johnson
Pharmaceutical

in preterm infants. Route 202, P.O. Box 300

TN= Procrit Raritan NJ 08869-0602

DD= 7/21/88 MA=

Epoetin alpha Treatment of HIV associated anemia R. W. Johnson
Pharmaceutical

related to HIV infection or HIV Route 202, P.O. Box 300

TN= Procrit treatment. Raritan NJ 08869

DD= 3/7/89 MA=

Epoetin beta Treatment of anemia associated with Chugai-USA, Inc.

end stage renal disease. 3780 Hawthorn Court

TN= Marogen Waukegan IL 60087

DD= 10/22/87 MA=

Epoprostenol Treatment of primary pulmonary Glaxo Wellcome Inc.

hypertension. 5 Moore Drive

TN= Flolan Research Triangle Park NC 27709

DD= 9/25/85 MA= 9/20/95

Epoprostenol Replacement of heparin in patients Glaxo Wellcome Inc.

requiring hemodialysis and who are 5 Moore Drive

TN= Flolan at increased risk of hemorrhage. Research Triangle Park NC
27709

DD= 3/29/84 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Epoprostenol Replacement of heparin in patients Upjohn Company

requiring hemodialysis and who are 301 Henrietta Street

TN= Cycloprostin at increased risk of hemorrhage. Kalamazoo MI 49001

DD= 10/29/84 MA=

Epoprostenol Treatment of secondary pulmonary Glaxo Wellcome Inc.

hypertension due to intrinsic Five Moore Dr.

TN= Flolan precapillary pulmonary vascular PO Box 13398

disease.

Research Triangle Park NC

DD= 3/22/99 MA= 4/14/00

Erwinia L-asparaginase Treatment of acute lymphocytic Porton
International, Inc.

leukemia. 7114 Springbrook Terrace, #200

TN= Erwinase Spotsylvania VA 22553

DD= 7/30/86 MA=

Erwinia L-asparaginase For use as an alternative to E. Lyphomed, Inc.

coli asparaginase in those

TN= situations where repeat courses of

asparaginase therapy for acute

lymphoblastic leukemia are required

or where allergic reactions force

DD= 1/25/85 MA=

Erythropoietin (human, Treatment of anemia associated with Organon
Teknika Corporation

recombinant) end stage renal disease.

TN=

DD= 11/19/87 MA=

Erythropoietin Treatment of anemia associated with McDonnell Douglas
Corp

(recombinant human) end stage renal disease. P.O. Box 516, 107/2 MS10

TN= St. Louis MO 63166

DD= 8/19/87 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Etanercept Reduction in signs and symptoms of Immunex Corporation

moderately to severely active 51 University St.

TN= Enbrel polyarticular-course juvenile Seattle WA 98101-2936

rheumatoid arthritis in patients

who have had an inadequate response

to one or more disease-modifying

DD= 10/27/98 MA= 5/27/99

Etanercept Treatment of Wegener\'s Immunex Corporation

granulomatosis. 51 University Street

TN= Enbrel Seattle WA 98101-2936

DD= 4/6/99 MA=

Ethanolamine oleate Treatment of patients with Block Drug Company, Inc.

esophageal varices that have 257 Cornelison Avenue

TN= Ethamolin recently bled, to prevent Jersey City NJ 07302

rebleeding.

DD= 3/22/84 MA= 12/22/88

Ethinyl Estradiol, USP Treatment of Turner\'s syndrome. Bio-Technology
General Corp.

70 Wood Avenue, South

TN= Iselin NJ 08830

DD= 6/22/88 MA=

Ethiofos Use as a chemoprotective agent for U.S. Bioscience

cisplatin and cyclophosphamide in

TN= the treatment of ovarian cancer.

DD= 8/1/89 MA=

Ethyl eicosapentaenoate Treatment of Huntington\'s disease. Laxdale Ltd.

Kings Park House, Laurelhill

TN= Polmaise Road, Stirling FK7 9JQ

United Kingdom UK

DD= 4/6/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Etidronate disodium Treatment of hypercalcemia of MGI Pharma, Inc.

malignancy inadequately managed by 6300 West Old Shakoppe Rd.

TN= Didronel dietary modification and/or oral Suite 110

hydration.

Bloomington MN 55438-2318

DD= 3/21/86 MA= 4/21/87

Etidronate disodium Prevention of degenerative MGI Pharma, Inc.

metabolic bone disease occurring in 6300 West Old Shakoppe Rd.

TN= Didronel IV infusion patients who require long term (6 Suite 110

months or greater) total parenteral

nutrition. Bloomington MN 55438-2318

DD= 5/2/91 MA=

Etidronate disodium Treatment of degenerative metabolic MGI Pharma, Inc.

bone disease occurring in patients 6300 West Old Shakoppe Rd.

TN= Didronel IV Infusion who require long term (6 months or Suite 110

greater) total parenteral

nutrition. Bloomington MN 55438-2318

DD= 5/2/91 MA=

Etiocholanedione Treatment of Prader-Willi syndrome. SuperGen, Inc.

Two Annabel Lane, Suite 220

TN= San Ramon CA 94583

DD= 5/7/96 MA=

Etiocholanedione Treatment of aplastic anemia. SuperGen, Inc.

Two Annabel Lane, Suite 220

TN= Suite 10

San Ramon CA 94583

DD= 11/3/95 MA=

Exemestane Treatment of advanced breast cancer Pharmacia & Upjohn

in postmenopausal women whose 7000 Portage Road

TN= Aromasin disease has progressed following Mail Stop: 0636-298-113

tamoxifen therapy.

Kalamazoo MI 49001-0199

DD= 9/19/91 MA= 10/21/99

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Exisulind For the suppression and control of Cell Pathways, Inc.

colonic adenomatous polyps in the 702 Electronic Drive

TN= inherited disease adenomatous Horsham PA 19044

polyposis coli.

DD= 2/14/94 MA=

Factor XIII concentrate Treatment of congenital factor XIII Aventis
Behring L.L.C.

(human) pasteurized deficiency. 1020 First Ave.

TN= Fibrogammin P PO Box 61501

King of Prussia PA 19406-0901

DD= 1/16/85 MA=

Factor XIII, recombinant Treatment of congenital factor XIII
Zymogenetics, Inc.

deficiency. 4225 Roosevelt Way

TN= Seattle WA 98105

DD= 4/22/93 MA=

Fampridine Treatment of chronic, incomplete Acorda Therapeutics, Inc.

spinal cord injury. 15 Skyline Dr.

TN= Neurelan Hawthorne NY 10532

DD= 6/2/97 MA=

Fampridine Relief of symptoms of multiple Acorda Therapeutics

sclerosis. 15 Skyline Dr.

TN= Neurelan Hawthorne NY 10532

DD= 6/2/87 MA=

Felbamate Treatment of Lennox-Gastaut Wallace Laboratories

syndrome. 301B College Road East

TN= Felbatol Princeton NJ 08540

DD= 1/24/89 MA= 7/29/93

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

FIAU Adjunctive treatment of chronic Oclassen Pharmaceuticals, Inc.

active hepatitis B. 100 Pelican Way

TN= San Rafael CA 94901

DD= 7/24/92 MA=

Fibrinogen (human) For the control of bleeding and Alpha Therapeutic
Corporation

prophylactic treatment of patients 5555 Valley Boulevard

TN= deficient in fibrinogen. Los Angeles CA 90032

DD= 8/23/95 MA=

Fibronectin (human Treatment of non-healing corneal Melville Biologics,
Inc.

plasma derived) ulcers or epithelial defects which 310 East 67th Street

TN= have been unresponsive to New York NY 10021

conventional therapy and the

underlying cause has been

eliminated.

DD= 9/5/88 MA=

Fibronectin (plasma Treatment of non-healing corneal Chiron Vision

derived) ulcers or epithelial defects which 9342 Jeronimo Road

TN= are unresponsive to conventional Irvine CA 92718

therapy and for which any

infectious cause of the defect has

been eliminated.

DD= 12/5/88 MA=

Filgrastim Reduction in the duration of Amgen, Inc.

neutropenia, fever, antibiotic use, One Amgen Center Dr.

TN= Neupogen and hospitalization, following Thousand Oaks CA 91320-1799

induction and consolidation

treatment for acute myeloid

leukemia.

DD= 11/7/96 MA= 4/2/98

Filgrastim Treatment of neutropenia associated Amgen, Inc.

with bone marrow transplants. 1840 Dehavilland Drive

TN= Neupogen Thousand Oaks CA 91320

DD= 10/1/90 MA= 6/15/94

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Filgrastim Treatment of patients with severe Amgen, Inc.

chronic neutropenia (absolute 1840 Dehavilland Drive

TN= Neupogen neutrophil count less than Thousand Oaks CA 91320

500/mm3).

DD= 11/7/90 MA= 12/19/94

Filgrastim Treatment of myelodysplastic Amgen, Inc.

syndrome. 1840 Dehavilland Drive

TN= Neupogen Thousand Oaks CA 91320

DD= 8/30/90 MA=

Filgrastim Treatment of patients with AIDS Amgen, Inc.

who, in addition, are afflicted One Amgen Center Dr.

TN= Neupogen with cytomegalovirus retinitis and Thousand Oaks CA
91320-1799

are being treated with ganciclovir.

DD= 9/3/91 MA=

Filgrastim For use in the mobilization of Amgen, Inc.

peripheral blood progenitor cells 1840 Dehavilland Drive

TN= Neupogen for collection in patients who will Thousand Oaks CA 91320

receive myeloablative or

myelosuppressive chemotherapy.

DD= 7/17/95 MA= 12/28/95

Flucinolone Treatment uveitis involving the Bausch & Lomb
Pharmaceuticals,

posterior segment of the eye. 8500 Hidden River Parkway

TN= Tampa FL 33637

DD= 7/31/00 MA=

Fludarabine phosphate Treatment and management of Berlex Laboratories,
Inc.

patients with non-Hodgkins 15049 San Pablo Avenue

TN= Fludara lymphoma. P.O. Box 4099

Richmond CA 94804-0099

DD= 4/18/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Fludarabine phosphate Treatment of chronic lymphocytic Berlex
Laboratories, Inc.

leukemia (CLL), including 15049 San Pablo Avenue, P.O. Box

TN= Fludara refractory CLL. Richmond CA 94804

DD= 4/18/89 MA= 4/18/91

Flumecinol Treatment of hyperbilirubinemia in Farmacon, Inc.

newborn infants unresponsive to Post House, Suite 213

TN= Zixoryn phototherapy. 1720 Post Road East

Westport CT 06880-5643

DD= 1/15/85 MA=

Flunarizine Treatment of alternating Janssen Research Foundation

hemiplegia.

TN= Sibelium P.O. Box 200

Titusville NJ 08560

DD= 1/6/86 MA=

Fluorouracil For use in combination with Lederle Laboratories

leucovorin for therapy of Division of American Cyanamid

TN= Adrucil metastatic adenocarcinoma of the 401 N. Middletown Road

colon and rectum.

Pearl River NY 10965

DD= 2/6/89 MA=

Fluorouracil For use in combination with Hoffmann-La Roche, Inc.

interferon alpha-2a, recombinant, 340 Kingsland Street

TN= for the treatment of esophageal Nutley NJ 07110-1199

carcinoma.

DD= 10/27/89 MA=

Fluorouracil Treatment of glioblastoma Ethypharm SA

multiforme. 194 Bureaux de la Colline -

TN= 92213 Saint-Cloud Cedex

France FR

DD= 6/29/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Fluorouracil For use in combination with Hoffmann-La Roche, Inc.

interferon alpha-2a, recombinant, 340 Kingsland Street

TN= for the treatment of advanced Nutley NJ 07110-1199

colorectal carcinoma.

DD= 4/18/90 MA=

Fluoxetine Treatment of autism. Hollander, MD, Eric

Mt. Sinai School of Medicine,

TN= Prozac Box 1230, One Gustave L. Levy

New York NY 10029-6574

DD= 4/30/99 MA=

Follitropin alfa, For the initiation and Serono Laboratories, Inc.

recombinant re-initiation of spermatogenesis in 100 Longwater Circle

TN= Gonal-F adult males with reproductive Norwell MA 02061

failure due to hypothalamic or

pituitary dysfunction,

hypogonadotropic hypogonadism.

DD= 12/21/98 MA= 5/24/00

Fomepizole Treatment of methanol or ethylene Orphan Medical, Inc.

glycol poisoning. 13911 Ridgedale Drive

TN= Antizole Suite 250

Minnetonka MN 55305

DD= 12/22/88 MA= 12/4/97

Fomepizole Treatment of methanol or ethylene Orphan Medical, Inc.

glycol poisoning. 13911 Ridgedale Drive

TN= Antizole Suite 250

Minnetonka MN 55305

DD= 12/22/88 MA= 12/8/00

Fosphenytoin For the acute treatment of patients Warner-Lambert Company

with status epilepticus of the 2800 Plymouth Road

TN= Cerebyx grand mal type. Ann Arbor MI 48106

DD= 6/4/91 MA= 8/5/96

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Fructose-1,6-diphosphate Treatment of painful vaso-occlusive Questcor
Pharmaceuticals, Inc.

episodes associated with sickle 26118 Research Road

TN= Cordox cell disease. Hayward CA 94545

DD= 5/29/98 MA=

Gabapentin Treatment of amyotrophic lateral Warner-Lambert Company

sclerosis. Parke-Davis Pharmaceutical

TN= Neurontin 2800 Plymouth Road

Ann Arbor MI 48105

DD= 7/5/95 MA=

Gallium nitrate Treatment of hypercalcemia of Solopak Pharmaceutical Co.

injection malignancy. 1845 Tonne Road

TN= Ganite Elk Grove Village IL 60007

DD= 12/5/88 MA= 1/17/91

Gamma hydroxybutyrate Treatment of narcolepsy and the Biocraft
Laboratories, Inc.

auxiliary symptoms of cataplexy, 18-01 River Road

TN= sleep paralysis, hypnagogic Fair Lawn NJ 07410

hallucinations and automatic

behavior.

DD= 12/22/87 MA=

Gamma-hydroxybutyric Treatment of narcolepsy and the Sigma Chemical
Company

acid auxiliary symptoms of cataplexy,

TN= sleep paralysis, hypnagogic

hallucinations, and automatic

behavior.

DD= 1/22/85 MA=

Gammalinolenic acid Treatment of juvenile rheumatoid Zurier, Robert B.
M.D.

arthritis. University of Massachusetts

TN= 55 Lake Avenue

Worcester MA 01655

DD= 7/27/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ganaxolone Treatment of infantile spasms. Purdue Pharma L.P.

100 Connecticut Ave.

TN= Norwalk CT 06850-3590

DD= 5/25/94 MA=

Ganciclovir intravitreal Treatment of cytomegalovirus Bausch & Lomb
Surgical, Chiron

implant retinitis. 9342 Jeronimo Road

TN= Vitrasert Implant Irvine CA 92718-1903

DD= 6/7/95 MA= 3/4/96

Ganciclovir sodium Treatment of cytomegalovirus Syntex (USA), Inc.

retinitis in immunocompromised 3401 Hillview Avenue

TN= Cytovene patients with AIDS. Palo Alto CA 94304

DD= 10/31/85 MA= 6/23/89

Gancyclovir Treatment of severe human Burroughs Wellcome Company

cytomegalovirus infections in 3030 Cornwallis Road

TN= specific immunosuppressed patient

populations.

DD= 6/7/85 MA=

Gangliosides as sodium Treatment of retinitis pigmentosa. Fidia
Pharmaceutical Corp.

salts 1401 Eye Street, N.W. Suite 900

TN= Cronassial Washington DC 20005

DD= 11/17/88 MA=

Gavilimomab Acute graft-versus-host disease Abgenix, Inc.

(aGVHD) 7601 Dumbarton Circle

TN= Fremont CA 94555

DD= 11/20/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Gemtuzumab zogamicin Treatment of CD33-positive acute Wyeth-Ayerst
Laboratories

myeloid leukemia. PO Box 8299

TN= Mylotarg Philadelphia PA 19101-8299

DD= 11/24/99 MA= 5/17/00

Gene plasmid hVEGF165 Prevention of complications due to Eurogene Ltd.

driven by human neointimal hyperplasia disease in 6 Warren Mews

TN= certain vascular anastomoses. London W1P 5DJ UK

DD= 10/24/00 MA=

Gentamicin impregnated Treatment of chronic osteomyelitis Lipha
Pharmaceuticals, Inc.

PMMA beads on surgical of post-traumatic, postoperative, 9 West 57th
Street

TN= Septopal or hematogenous origin. Suite 3825

New York NY 10019-2701

DD= 1/31/91 MA=

Gentamicin liposome Treatment of disseminated Liposome Company, Inc.

injection Mycobacterium avium-intracellulare One Research Way

TN= Maitec infection. Princeton NJ 08540

DD= 7/10/90 MA=

Glatiramer acetate Treatment of multiple sclerosis. Teva Pharmaceuticals
USA

1510 Delp Drive

TN= Copaxone Kulpsville PA 19443

DD= 11/9/87 MA= 12/20/96

Glutamine For use with human growth hormone Nutritional Restart

in the treatment of short bowel 4364 South Alston Avenue

TN= syndrome (nutrient malabsorption Durham NC 27713

from the gastrointestinal tract

resulting from an inadequate

absorptive surface).

DD= 3/6/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Glyceol To decrease intracranial Chugai Pharmaceutical Co., Ltd.

hypertension and/or alleviate

TN= cerebral edema in patients who may

benefit from osmotherapy.

DD= 2/22/90 MA=

Glyceryl trioleate and Treatment of adrenoleukodystrophy. Moser, Hugo W.
M.D.

glyceryl trierucate Johns Hopkins University

TN= Kennedy Krieger Institute, 707

Baltimore MD 21205

DD= 2/14/95 MA=

Gonadorelin acetate For induction of ovulation in women Ferring
Laboratories, Inc.

with hypothalamic amenorrhea due 400 Rella Boulevard, Suite 201

TN= Lutrepulse to a deficiency or absence in the Suffern NY 10901

quantity or pulse pattern of

endogenous GnRH secretion.

DD= 4/22/87 MA= 10/10/89

Gossypol Treatment of cancer of the adrenal Reidenberg, Marcus M. M.D.

cortex. The New York Hospital - Cornell

TN= 525 East 68th Street, Box 70

New York NY 10021

DD= 10/22/90 MA=

Gp100 adenoviral gene Treatment of metastatic melanoma. Genzyme
Corporation

therapy One Mountain Rd.

TN= P.O. Box 9322

Framingham MA 01701-9322

DD= 3/25/97 MA=

Granulocyte Treatment of myelodysplastic Schering Corporation

macrophage-colony syndrome. 2000 Galloping Hill Road

TN= Leucomax Kenilworth NJ 07033

DD= 8/7/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Granulocyte Treatment of chronic lymphocytic Schering Corporation

macrophage-colony leukemia to increase granulocyte 2000 Galloping Hill
Road

TN= Leucomax count. Kenilworth NJ 07033

DD= 5/4/90 MA=

Granulocyte Treatment of neutropenia associated Schering Corporation

macrophage-colony with bone marrow transplants. 2000 Galloping Hill Road

TN= Leucomax Kenilworth NJ 07033

DD= 12/12/89 MA=

Granulocyte Treatment of severe thermal Schering Corporation

macrophage-colony injuries in patients with greater 2000 Galloping Hill
Road

TN= Leucomax than 40% full or partial thickness Kenilworth NJ 07033

burns.

DD= 6/6/89 MA=

Granulocyte Treatment of neutropenia due to Schering Corporation

macrophage-colony hairy cell leukemia. 2000 Galloping Hill Road

TN= Leucomax Kenilworth NJ 07033

DD= 5/3/90 MA=

Group B streptococcus Treatment of neonates for North American
Biologicals, Inc.

immune globulin disseminated group B streptococcal 12280 Wilkins Avenue

TN= infection. Rockville MD 20852

DD= 5/8/90 MA=

Growth hormone releasing For the long-term treatment of ICN
Pharmaceuticals, Inc.

factor children who have growth failure ICN Plaza

TN= due to a lack of adequate 3300 Hyland Avenue

endogenous growth hormone

secretion. Costa Mesa CA 92626

DD= 8/7/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Guanethidine monosulfate Treatment of moderate to severe Novartis
Pharmaceuticals

reflex sympathetic dystrophy and 59 Route 10

TN= Ismelin causalgia. East Hanover NJ 07936-1080

DD= 1/6/86 MA=

Guanfacine Treatment of fragile X syndrome. Watson Laboratories, Inc.

311 Bonnie Circle

TN= Tenex PO Box 1900

Corona CA 91718-1900

DD= 8/5/99 MA=

Gusperimus Treatment of acute renal graft Bristol-Myers Squibb

rejection episodes. 5 Research Parkway

TN= Spanidin P.O. Box 5100

Wallingford CT 06492-7660

DD= 6/27/96 MA=

h5G1.1-mAb Treatment of dermatomyositis Alexion Pharmaceuticals, Inc.

352 Knotter Drive

TN= Cheshire CT 06410

DD= 9/21/00 MA=

Halofantrine Treatment of mild to moderate acute SmithKline Beecham

malaria caused by susceptible One Franklin Plaza

TN= Halfan strains of P. falciparum and P. P.O. Box 7929

vivax.

Philadelphia PA 19101

DD= 11/4/91 MA= 7/24/92

Halofuginone Treatment of systemic sclerosis. Collgard
Biopharmaceuticals Ltd.

Textile House, 2 Koifman St.

TN= Stenorol Tel-Aviv 68012

Israel IL

DD= 2/7/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Heme arginate Treatment of myelodysplastic Berlex Laboratories, Inc.

syndromes. 15049 San Pablo Avenue

TN= Normosang Richmond CA 94804-0099

DD= 3/1/94 MA=

Heme arginate Treatment of symptomatic stage of Berlex Laboratories,
Inc.

acute porphyria. 15049 San Pablo Avenue

TN= Normosang Richmond CA 94804-0099

DD= 3/10/88 MA=

Hemin Amelioration of recurrent attacks Abbott Laboratories

of acute intermittent porphyria Diagnostics Division

TN= Panhematin (AIP) temporarily related to the Abbott Park IL 60064

menstrual cycle in susceptible

women and similar symptoms which

occur in other patients with AIP,

DD= 3/16/84 MA= 7/20/83

Hemin and zinc Treatment of acute porphyric Bonkovsky, Herbert L. M.D.

mesoporphyrin syndromes. University Of Massachusetts

TN= Hemex 55 Lake Avenue North

Worcester MA 01655

DD= 12/20/93 MA=

Hepatitis B immune Prophylaxis against hepatitis B NABI

globulin intravenous virus reinfection in liver 12280 Wilkins Avenue

TN= Nabi-HB transplant patients. Rockville MD 20852

DD= 3/8/95 MA=

Herpes simplex virus Treatment of primary and metastatic Genetic
Therapy, Inc.

gene brain tumors. 938 Clopper Road

TN= Gaithersburg MD 20878

DD= 10/16/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Histamine Adjunct to cytokine therapy in the Maxim Pharmaceuticals, Inc.

treatment of acute myeloid 8899 University Center Lane

TN= Maxamine leukemia. Suite 400

San Diego CA 92122

DD= 12/15/99 MA=

Histamine For use as an adjunct to cytokine Maxim Pharmaceuticals, Inc.

therapy in the treatment of 8899 University Center Lane

TN= Maxamine malignant melanoma. Suite 400

San Diego CA 92122

DD= 2/1/00 MA=

Histrelin Treatment of acute intermittent Anderson, Karl E., M.D.

porphyria, hereditary University of Texas Medical

TN= coproporphyria, and variegate Route J-09, 700 The Strand

porphyria.

Galveston TX 77550

DD= 5/3/91 MA=

Histrelin acetate Treatment of central precocious Roberts Pharmaceutical
Corp.

puberty. Meridian Center III

TN= Supprelin Injection 6 Industrial Way West

Eatontown NJ 07724

DD= 8/10/88 MA= 12/24/91

HIV neutralizing Treatment of acquired Hemacare Corporation

antibodies immunodeficiency syndrome. 4954 Van Nuys Boulevard

TN= Immupath Sherman Oaks CA 91403

DD= 3/24/92 MA=

HLA-B7/Beta2M DNA Lipid Treatment of invasive and Vical Incorporated

(DMRIE/DOPE) Complex metastatic melanoma (Stages II, 9373 Towne Centre
Dr., Suite 100

TN= Allovectin-7 III, and IV). San Diego CA 92121

DD= 9/30/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

HPA-23 Treatment of acquired Rhone-Poulenc Rorer Pharm.

immunodeficiency syndrome. 500 Arcola Road

TN= Collegeville PA 19426

DD= 7/17/85 MA=

Human acid precursor Treatment of glycogen storage Pharming/Genzyme LLC

alpha-glucosidase, disease type II. c/o Genzyme Corporation

TN= 1 Mountain Rd.

Framingham MA 01701-9322

DD= 9/10/96 MA=

Human IgM monoclonal Treatment of cytomegalovirus Centocor, Inc.

antibody (C-58) To CMV infections in allogenic bone marrow 244 Great
Valley Parkway

TN= Centovir transplant patients. Malvern PA 19355

DD= 8/7/89 MA=

Human IgM monoclonal Prophylaxis of cytomegalovirus Centocor, Inc.

antibody (C-58) To CMV infections in bone marrow 244 Great Valley
Parkway

TN= Centovir transplant patients. Malvern PA 19355

DD= 8/7/89 MA=

Human immunodeficiency Treatment of HIV-infected pediatric NABI

virus immune globulin patients. 5800 Park of Commerce Blvd., NW

TN= Hivig Boca Raton FL 33487

DD= 1/4/95 MA=

Human immunodeficiency Treatment of HIV-infected pregnant NABI

virus immune globulin women and infants of HIV-infected 5800 Park of
Commerce Blvd.,

TN= mothers. Boca Raton FL 33487

DD= 3/25/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Human immunodeficiency Treatment of AIDS. NABI

virus immune globulin 5800 Park of Commerce Blvd., NW

TN= Boca Raton FL 33487

DD= 11/21/89 MA=

Human T-lymphotropic Treatment of AIDS. MicroGeneSys, Inc.

virus type III Gp160 1000 Research Parkway

TN= Vaxsyn HIV-1 Meriden CT 06450

DD= 11/20/89 MA=

Humanized anti-CD2 Treatment of graft-versus-host MedImmune, Inc.

monoclonal antibody disease. 35 West Watkins Mill Rd.

TN= Gaithersburg MD 20878

DD= 11/13/98 MA=

Humanized anti-human CD2 For the induction of donor-specific
Biotransplant, Inc.

MAb immunologic unresponsiveness Building 75, 3rd. Ave.

TN= MEDI-507 resulting in prophylaxis of organ Charlestown Navy Yard

rejection without the need for

chronic immunosuppressive therapy, Charlestown MA 02129

in patients receiving allogeneic

DD= 9/17/98 MA=

Humanized anti-tac Prevention of acute graft-vs-host Hoffmann-La Roche,
Inc.

disease following bone marrow 340 Kingsland Street

TN= Zenapax transplantation. Nutley NJ 07110-1199

DD= 3/5/93 MA=

Humanized MAb (IDEC-131) Treatment of systemic lupus Idec
Pharmaceuticals Corporation

to CD40L erythematosus. 3030 Callan Rd.

TN= San Diego CA 92121

DD= 2/9/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Hydroxycobalamin Treatment of acute cyanide Orphan Medical, Inc.

poisoning 13911 Ridgedale Drive

TN= CYANOKIT Suite 250

Minnetonka MN 55305

DD= 9/22/00 MA=

Hydroxycobalamin/sodium Treatment of severe acute cyanide Hall, Alan H.,
M.D.

thiosulfate poisoning. Mile 5.0 Pass Creek Road

TN= PO Box 24

Elk Mountain WY 82324

DD= 10/4/85 MA=

Hydroxyurea Treatment of patients with sickle Bristol-Myers Squibb

cell anemia as shown by the P.O. Box 4000

TN= Droxia presence of hemoglobin S. Princeton NJ 08543

DD= 10/1/90 MA= 2/25/98

Hypericin Treatment of cutaneous T-cell Nexell Therapeutics, Inc.

lymphoma. 2751 Centerville Rd., Suite 210

TN= Wilmington DE 19808

DD= 2/7/00 MA=

Hypericin Treatment of glioblastoma Nexell Therapeutics

multiforme. 2751 Centerville Rd., Suite 210

TN= Wilmington DE 19808

DD= 8/3/00 MA=

Ibuprofen i.v. solution Prevention of patent ductus Farmacon-IL, LLC

arteriosus. 1720 Post Road East

TN= Salprofen Suite 213

Westport CT 06880-5643

DD= 10/29/96 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ibuprofen i.v. solution Treatment of patent ductus Farmacon-IL-LLC

arteriosus. 1720 Post Road East

TN= Suite 213

Westport CT 06880-5643

DD= 10/29/96 MA=

Icodextrin 7.5% with Treatment of those patients having Baxter
Healthcare Corporation

Electrolytes Peritoneal end stage renal disease and Renal Division

TN= Extraneal (with 7.5% requiring peritoneal dialysis 1620 Waukegan
Road

treatment.

McGaw Park IL 60085

DD= 7/18/97 MA=

Idarubicin Treatment of chronic myelogenous Pharmacia & Upjohn

leukemia. 7000 Portage Road

TN= Idamycin Unit 0633-298-113

Kalamazoo MI 49001-0199

DD= 12/2/92 MA=

Idarubicin Treatment of myelodysplastic Pharmacia & Upjohn

syndromes. 7000 Portage Road

TN= Idamycin Unit 0633-298-113

Kalamazoo MI 49001-0199

DD= 12/1/92 MA=

Idarubicin HCl for Treatment of acute lymphoblastic Pharmacia & Upjohn

injection leukemia in pediatric patients. 7000 Portage Road

TN= Idamycin Unit 0633-298-113

Kalamazoo MI 49001-0199

DD= 2/12/91 MA=

Idarubicin HCl for Treatment of acute myelogenous Adria Laboratories,
Inc.

injection leukemia, also referred to as acute P.O. Box 16529

TN= Idamycin nonlymphocytic leukemia. Columbus OH 43216

DD= 7/25/88 MA= 9/27/90

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Idoxuridine Treatment of nonparenchymatous NeoPharm, Inc.

sarcomas. 225 East Deerpath, Suite 250

TN= Lake Forest IL 60045

DD= 4/8/96 MA=

Ifosfamide Treatment of testicular cancer. Bristol-Myers Squibb

5 Research Parkway, P.O. Box

TN= Ifex Wallingford CT 06492

DD= 1/20/87 MA= 12/30/88

Ifosfamide Treatment of bone sarcomas. Bristol-Myers Squibb

P.O. Box 4000

TN= Ifex Princeton NJ 08543-4000

DD= 8/7/85 MA=

Ifosfamide Treatment of soft tissue sarcomas. Bristol-Myers Squibb

P.O. Box 4000

TN= Ifex Princeton NJ 08543

DD= 8/7/85 MA=

IL-4 Pseudomonas Toxin Treatment of astrocytic glioma. Neurocrine
Biosciences, Inc.

Fusion Protein 10555 Science Center Dr.

TN= San Diego CA 92121

DD= 4/6/00 MA=

Iloprost solution for Treatment of heparin-associated Berlex
Laboratories, Inc.

infusion thrombocytopenia. 300 Fairfield Road

TN= Wayne NJ 07470

DD= 5/14/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Iloprost solution for Treatment of Raynaud\'s phenomenon Berlex
Laboratories, Inc.

infusion secondary to systemic sclerosis. 300 Fairfield Road

TN= Wayne NJ 07470

DD= 9/21/89 MA=

Imatinib Treatment of chronic myelogenous Novartis Pharmaceuticals

leukemia 59 Route 10

TN= Glivec East Hanover NJ 07936-1080

DD= 1/31/01 MA=

Imciromab pentetate Detecting early necrosis as an Centocor, Inc.

indication of rejection of 244 Great Valley Parkway

TN= Myoscint orthotopic cardiac transplants. Malvern PA 19355

DD= 1/25/89 MA=

Imexon Treatment of multiple myeloma. AmpliMed Corporation

2321 Camino La Zorrela

TN= Tucson AZ 85718

DD= 11/8/96 MA=

Imiglucerase Replacement therapy in patients Genzyme Corporation

with types I, II, and III Gaucher\'s One Kendall Square

TN= Cerezyme disease. Cambridge MA 02139-1562

DD= 11/5/91 MA= 5/23/94

Immune globulin Treatment of patients with acute Immuno Clinical
Research Corp.

intravenous (human) myocarditis. 750 Lexington Avenue

TN= Immune Globulin New York NY 10022

DD= 11/22/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Immune globulin Treatment of juvenile rheumatoid Immuno Clinical
Research Corp.

intravenous (human) arthritis. 750 Lexington Avenue, 19th Floor

TN= Iveegam, Immuno New York NY 10022

DD= 12/16/92 MA=

Immune globulin Treatment of Immuno Clinical Research Corp.

intravenous (human) polymyositis/dermatomyositis. 155 East 56th Street

TN= Iveegam, Immuno New York NY 10022

DD= 10/13/92 MA=

Immune globulin Infection prophylaxis in pediatric Bayer Corporation

intravenous, human patients affected with the human Pharmaceutical
Division,

TN= Gamimune N immunodeficiency virus. 400 Morgan Lane

New Haven CT 06516

DD= 2/18/93 MA= 12/27/93

Imported fire ant venom, For skin testing of victims of fire ALK
Laboratories, Inc.

allergenic extract ant stings to confirm fire ant Research Center

TN= sensitivity and if positive, for 27 Village Lane

use as immunotherapy for the

prevention of IgE-mediated Wallingford CT 06492

anaphylactic reactions.

DD= 5/12/92 MA=

Indium In 111 murine To aid in the diagnosis of Centocor, Inc.

monoclonal antibody FAB myocarditis. 244 Great Valley Parkway

TN= Myoscint Malvern PA 19355

DD= 8/7/89 MA=

Indium In-111 altumomab Detection of suspected and Hybritech, Inc.

pentetate previously unidentified tumor foci 11095 Torreyanna Road

TN= Hybri-ceaker of recurrent colorectal carcinoma. San Diego CA 92196

DD= 2/6/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Indium-In-111 murine Treatment of B-cell non-Hodgkin\'s IDEC
Pharmaceuticals Corporation

MAb(2B8-MX-DTPA) & lymphoma. 3030 Callan Road

TN= Melimmune San Diego CA 92121

DD= 9/6/94 MA=

Infliximab Treatment of moderately to severely Centocor, Inc.

active Crohn\'s disease for the 200 Great Valley Parkway

TN= Remicade reduction of the signs and Malvern PA 19355-1307

symptoms, in patients who have an

inadequate response to conventional

therapy; and treatment of patients

DD= 11/14/95 MA= 8/24/98

Inosine pranobex Treatment of subacute sclerosing Newport
Pharmaceuticals

panencephalitis. 897 West Sixteenth Street

TN= Isoprinosine Newport Beach CA 92663

DD= 9/20/88 MA=

Interferon alfa-2a Treatment of chronic myelogenous Hoffmann-La Roche,
Inc.

leukemia. 340 Kingsland Street

TN= Roferon A Nutley NJ 07110

DD= 6/6/89 MA= 10/19/95

Interferon alfa-2a For the concomitant administration Hoffmann-La Roche,
Inc.

(recombinant) with fluorouracil for the treatment 340 Kingsland Street

TN= Roferon-A of advanced colorectal cancer. Nutley NJ 07110-1199

DD= 5/14/90 MA=

Interferon alfa-2a For the treatment of metastatic Hoffmann-La Roche,
Inc.

(recombinant) malignant melanoma in combination 340 Kingsland Street

TN= Roferon-A with Teceleukin. Nutley NJ 07110

DD= 5/11/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interferon alfa-2a Treatment of renal cell carcinoma. Hoffmann-La Roche,
Inc.

(recombinant) 340 Kingsland Street

TN= Roferon-A Nutley NJ 07110-1199

DD= 4/18/88 MA=

Interferon alfa-2a For use in combination with Hoffmann-La Roche, Inc.

(recombinant) fluorouracil for the treatment of 340 Kingsland Street

TN= Roferon-A esophageal carcinoma. Nutley NJ 07110-1199

DD= 10/27/89 MA=

Interferon alfa-2a For the concomitant administration Hoffmann-La Roche,
Inc.

(recombinant) with Teceleukin for the treatment 340 Kingsland Street

TN= Roferon-A of metastatic renal cell carcinoma. Nutley NJ 07119

DD= 5/2/90 MA=

Interferon alfa-2a Treatment of AIDS related Kaposi\'s Hoffmann-La
Roche, Inc.

(recombinant) sarcoma. 340 Kingsland Street

TN= Roferon-A Nutley NJ 07110

DD= 12/14/87 MA= 11/21/88

Interferon alfa-2b Treatment of ovarian carcinoma. Schering Corporation

(recombinant) 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 8/3/87 MA=

Interferon alfa-2b Treatment of carcinoma in situ of Schering
Corporation

(recombinant) the urinary bladder. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 8/10/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interferon alfa-2b Treatment of acute hepatitis B. Schering Corporation

(recombinant) 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 11/17/88 MA=

Interferon alfa-2b Treatment of invasive carcinoma of Schering
Corporation

(recombinant) the cervix. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 4/18/88 MA=

Interferon alfa-2b Treatment of chronic myelogenous Schering Corporation

(recombinant) leukemia. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 6/22/87 MA=

Interferon alfa-2b Treatment of chronic delta Schering Corporation

(recombinant) hepatitis. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 5/4/90 MA=

Interferon alfa-2b Treatment of primary malignant Schering Corporation

(recombinant) brain tumors. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 5/13/88 MA=

Interferon alfa-2b Treatment of laryngeal Schering Corporation

(recombinant) (respiratory) papillomatosis. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 8/17/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interferon alfa-2b Treatment of metastatic renal cell Schering
Corporation

(recombinant) carcinoma. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 6/22/87 MA=

Interferon alfa-2b Treatment of AIDS-related Kaposi\'s Schering
Corporation

(recombinant) sarcoma. 2000 Galloping Hill Road

TN= Intron A Kenilworth NJ 07033

DD= 6/24/87 MA= 11/21/88

Interferon alfa-nl Treatment of human papillomavirus Glaxo Wellcome Inc.

in patients with severe 5 Moore Drive

TN= Wellferon resistant/recurrent respiratory Research Triangle Park NC
27709

(laryngeal) papillomatosis.

DD= 10/16/87 MA=

Interferon alfa-nl Treatment of AIDS related Kaposi\'s Burroughs
Wellcome Company

sarcoma. 3030 Cornwallis Road

TN= Wellferon Research Triangle Pk NC 27709

DD= 8/25/86 MA=

Interferon beta Treatment of primary brain tumors. Biogen, Inc.

(recombinant human) 14 Cambridge Center

TN= Avonex Cambridge MA 02142

DD= 1/13/93 MA=

Interferon beta For the systemic treatment of Biogen, Inc.

(recombinant) metastatic renal cell carcinoma. 14 Cambridge Center

TN= R-IFN-beta Cambridge MA 02142

DD= 2/12/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interferon beta For the systemic treatment of Biogen, Inc.

(recombinant) cutaneous T-cell lymphoma. 14 Cambridge Center

TN= r-HuIFN-beta Cambridge MA 02142

DD= 4/18/91 MA=

Interferon beta For the intralesional and/or Biogen, Inc.

(recombinant) systemic treatment of AIDS-related 14 Cambridge Center

TN= r-HuIFN-beta Kaposi\'s sarcoma. Cambridge MA 02142

DD= 5/9/91 MA=

Interferon beta, Treatment of acquired Berlex Laboratories, Inc.

recombinant human immunodeficiency syndrome. 15049 San Pablo Avenue,
P.O. Box

TN= Betaseron Richmond CA 94804

DD= 11/15/88 MA=

Interferon beta-1a Treatment of multiple sclerosis. Biogen, Inc.

14 Cambridge Center

TN= Avonex Cambridge MA 02142

DD= 12/16/91 MA= 5/16/96

Interferon beta-1a Treatment of patients with Serono Laboratories, Inc.

secondary progressive multiple 100 Longwater Circle

TN= Rebif sclerosis. Norwell MA 02061

DD= 3/11/96 MA=

Interferon Beta-1a Treatment of juvenile rheumatoid Biogen, Inc.

arthritis. 14 Cambridge Center

TN= Avonex Cambridge MA 02142

DD= 10/14/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interferon beta-1a Treatment of acute non-A, non-B Biogen, Inc.

(recombinant human) hepatitis. 14 Cambridge Center

TN= Cambridge MA 02142

DD= 7/24/92 MA=

Interferon beta-1a Treatment of pulmonary fibrosis. Biogen, Inc.

(recombinant human) 14 Cambridge Center

TN= Avonex Cambridge MA 02142

DD= 1/7/99 MA=

Interferon beta-1a Treatment of symptomatic patients Serono
Laboratories, Inc.

(recombinant) with AIDS including all patients 100 Longwater Circle

TN= Rebif with CD4 T-cell counts less than Norwell MA 02061

200 cells per mm3.

DD= 12/2/92 MA=

Interferon beta-1a For the systemic treatment of Biogen, Inc.

(recombinant) cutaneous malignant melanoma. 14 Cambridge Center

TN= r-HuIFN-beta Cambridge MA 02142

DD= 4/3/91 MA=

Interferon beta-1b Treatment of multiple sclerosis. Chiron Corp. &
Berlex

4560 Horton Street

TN= Betaseron Emeryville CA 94608

DD= 11/17/88 MA= 7/23/93

Interferon gamma 1-b Treatment of chronic granulomatous Genentech, Inc.

disease. 460 Point San Bruno Boulevard

TN= Actimmune South San Francisco CA 94080

DD= 9/30/88 MA= 12/20/90

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interferon gamma-1b Treatment of renal cell carcinoma. Genentech, Inc.

1 DNA Way

TN= Actimmune South San Francisco CA

DD= 12/4/95 MA=

Interferon gamma-1b Delaying time to disease InterMune Pharmaceuticals,
Inc.

progression in patients with 3294 West Bayshore Road

TN= Actimmune severe, malignant osteopetrosis. Palo Alto CA 94303

DD= 9/30/96 MA= 2/10/00

Interleukin-1 alpha, For the promotion of early Immunex Corporation

human recombinant engraftment in bone marrow 51 University Street

TN= transplantation. Seattle WA 98101

DD= 6/17/91 MA=

Interleukin-1 alpha, For hematopoietic potentiation in Immunex
Corporation

human recombinant aplastic anemia. 51 University Street

TN= Seattle WA 98101

DD= 6/17/91 MA=

Interleukin-1 receptor Treatment of juvenile rheumatoid Amgen, Inc.

antagonist, human arthritis. One Amgen Center Drive

TN= Antril Thousand Oaks CA 91320-1799

DD= 9/23/91 MA=

Interleukin-1 receptor Prevention and treatment of graft Amgen, Inc.

antagonist, human versus host disease in transplant One Amgen Center
Drive

TN= Antril recipients. Thousand Oaks CA 91320-1799

DD= 10/16/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Interleukin-2 In combination with interferon Hoffmann-La Roche, Inc.

alfa-2a for the treatment of 340 Kingsland Street

TN= Teceleukin metastatic renal cell carcinoma. Nutley NJ 07110

DD= 5/3/90 MA=

Interleukin-2 Treatment of metastatic malignant Hoffmann-La Roche, Inc.

melanoma. 340 Kingsland Street

TN= Teleleukin Nutley NJ 07110

DD= 2/6/90 MA=

Interleukin-2 Treatment of metastatic renal cell Hoffmann-La Roche, Inc.

carcinoma. 340 Kingsland Street

TN= Teceleukin Nutley NJ 07110

DD= 2/5/90 MA=

Interleukin-2 In combination with interferon Hoffmann-La Roche, Inc.

alfa-2a for the treatment of 340 Kingsland Street

TN= Teceleukin metastatic malignant melanoma. Nutley NJ 07110

DD= 5/11/90 MA=

Interleukin-3 human Promotion of erythropoiesis in Immunex Corporation

(recombinant) Diamond-Blackfan anemia (congenital 51 University Street

TN= pure red cell aplasia). Seattle WA 98101

DD= 5/20/91 MA=

Interleukin-3, human, For sequential administration with Sandoz
Pharmaceuticals Corp.

recombinant sargramostim to accelerate 59 Route 10

TN= neutrophil and platelet recovery in East Hanover NJ 07936

patients undergoing autologous

bone marrow transplantation for the

treatment of Hodgkin\'s disease or

DD= 9/30/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Iobenguane Sulfate I 131 For use as a diagnostic adjunct in University
of Michigan

patients with pheochromocytoma. UH B1 H410/0028

TN= 1500 E. Medical Center Drive

Ann Arbor MI 48109-0028

DD= 11/14/84 MA= 3/21/90

Iodine 131 For use in adrenal cortical David E. Kuhl, M.D.

6B-iodomethyl-19-norchol imaging. University of Michigan Medical

TN= B1G412 /0028 University Hospital

Ann Arbor MI 48109-0028

DD= 8/1/84 MA=

Iodine I 123 murine Detection of alpha-fetoprotein Immunomedics, Inc.

monoclonal antibody to producing germ cell tumors. 300 American Road

TN= Morris Plains NJ 07950

DD= 9/30/88 MA=

Iodine I 123 murine Detection of hepatocellular Immunomedics, Inc.

monoclonal antibody to carcinoma and hepatoblastoma. 300 American Road

TN= Morris Plains NJ 07950

DD= 9/30/88 MA=

Iodine I 123 murine Detection of hCG producing tumors Immunomedics, Inc.

monoclonal antibody to such as germ cell and trophoblastic 300 American
Road

TN= cell tumors. Morris Plains NJ 07950

DD= 11/7/88 MA=

Iodine I 131 Treatment of small-cell lung IBC Pharmaceuticals, L.L.C.

bis(indium-diethylenetri cancer. 300 American Rd.

TN= Pentacea Morris Plains NJ 07950

DD= 2/22/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Iodine I 131 Lym-1 Treatment of B-cell lymphoma. Lederle Laboratories
Division

Monoclonal Antibody American Cyanamide Company

TN= Pearl River NY 10965

DD= 11/2/87 MA=

Iodine I 131 murine Treatment of B-cell leukemia and Immunomedics, Inc.

monoclonal antibody B-cell lymphoma. 300 American Road

TN= Immurait, Ll-2-I-131 Morris Plains NJ 07950

DD= 9/18/89 MA=

Iodine I 131 murine Treatment of hepatocellular Immunomedics, Inc.

monoclonal antibody to carcinoma and hepatoblastoma. 300 American Road

TN= Morris Plains NJ 07950

DD= 9/30/88 MA=

Iodine I 131 murine Treatment of alpha-fetoprotein Immunomedics, Inc.

monoclonal antibody to producing germ cell tumors. 300 American Road

TN= Morris Plains NJ 07950

DD= 9/30/88 MA=

Iodine I 131 murine Treatment of hCG producing tumors Immunomedics, Inc.

monoclonal antibody to such as germ cell and trophoblastic 300 American
Road

TN= cell tumors. Morris Plains NJ 07950

DD= 11/7/88 MA=

Iodine I-131 Treatment of glioblastoma Techniclone Corporation

radiolabeled chimeric multiforme and anaplastic 14282 Franklin Ave.

TN= 131IchTNT-1 astrocytoma. Tustin CA 92780-7017

DD= 2/12/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Isobutyramide Treatment of sickle cell disease Alpha Therapeutic
Corporation

and beta thalassemia. 5555 Valley Boulevard

TN= Los Angeles CA 90032

DD= 5/25/94 MA=

Isobutyramide Treatment of Perrine, Susan P., M.D.

beta-hemoglobinopathies and Boston University

TN= Isobutyramide oral beta-thalassemia syndromes. Cancer Research
Center

Boston MA 02118

DD= 12/18/92 MA=

Japanese encephalitis Prevention of Japanese Boran Pharmaceuticals

vaccine (live, encephalitis. 3F, Koryo Academytel, 437-3

TN= Ahyun-Dong, Mapo-Gu, Seoul

South Korea KR

DD= 5/19/99 MA=

Ketoconazole For use with cyclosporine A to Pharmedic Company

diminish the nephrotoxicity induced 28101 Ballard Road

TN= Nizoral by cyclosporine in organ Lake Forest IL 60045

transplantation.

DD= 3/27/91 MA=

L-2-oxothiazolidine-4-ca Treatment of adult respiratory Transcend
Therapeutics, Inc.

rboxylic acid distress syndrome. 640 Memorial Drive, 3rd Floor

TN= Procysteine Cambridge MA 02139

DD= 6/14/94 MA=

L-2-oxothiazolidine-4-ca Treatment of amyotrophic lateral Transcend
Therapeutics, Inc.

rboxylic acid sclerosis. 640 Memorial Drive, 3rd Floor

TN= Procysteine Cambridge MA 02139

DD= 7/30/96 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

L-5-hydroxytryptophan Treatment of tetrahydrobiopterin Watson
Laboratories, Inc.

deficiency. 311 Bonnie Circle

TN= P.O. Box 1900

Corona CA 91718-1900

DD= 1/20/99 MA=

L-baclofen Treatment of trigeminal neuralgia. Pharmascience Inc.

6111 Royalmount, #100

TN= Montreal, Quebec

Canada H4P 2T4 CA

DD= 1/6/98 MA=

L-baclofen Treatment of trigeminal neuralgia. Fromm, Gerhard M.D.

University Of Pittsburgh School

TN= Pittsburgh PA 15261

DD= 7/13/90 MA=

L-baclofen Treatment of intractable spasticity Pharmascience Inc.

in children with cerebral palsy. 6111 Royalmount, Suite 100

TN= Neuralgon Montreal, Quebec H4P 2T4

Canada CA

DD= 1/30/92 MA=

L-baclofen Treatment of intractable spasticity Pharmascience Inc.

associated with spinal cord injury 6111 Royalmount, Suite 100

TN= Neuralgon or multiple sclerosis. Montreal, Quebec H4P 2T4

Canada CA

DD= 12/17/91 MA=

L-cycloserine Treatment of Gaucher\'s disease. Lev, Meir M.D.

The City College, City

TN= Convent Avenue at 138 Street

New York NY 10031

DD= 8/1/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

L-cysteine For the prevention and lessening of Orphan Pharmaceuticals,
U.S.A.,

photosensitivity in erythropoietic 1101 Kermit Dr.

TN= protoporphyria. Suite 608

Nashville TN 37217

DD= 5/16/94 MA=

L-glutamyl-L-tryptophan Treatment of AIDS-related Kaposi\'s Cytran
Incorporated

sarcoma. 10230 N.E. Points Dr.

TN= Suite 530

Kirkland WA 98033-7869

DD= 10/20/99 MA=

L-leucovorin For use in conjunction with Lederle Laboratories

high-dose methotrexate in the Division of American Cyanamid

TN= Isovorin treatment of osteosarcoma. 401 N. Middletown Road

Pearl River NY 10965

DD= 8/1/91 MA=

L-leucovorin For use in combination chemotherapy Lederle Laboratories

with the approved agent Division of American Cyanamid

TN= Isovorin 5-fluorouracil in the palliative 401 N. Middletown Road

treatment of metastatic

adenocarcinoma of the colon and Pearl River NY 10965

rectum.

DD= 12/18/90 MA=

L-threonine Treatment of spasticity associated Interneuron
Pharmaceuticals,

with familial spastic paraparesis. 99 Hayden Ave., Suite 200

TN= Lexington MA 02421-7966

DD= 7/24/92 MA=

L-threonine Treatment of amyotrophic lateral Tyson And Associates

sclerosis. 12832 Chadron Avenue

TN= Threostat Hawthorne CA 90250

DD= 2/6/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Lactic acid Treatment of severe aphthous Frontier Pharmaceutical, Inc.

stomatitis in severely, terminally SUNY Farmingdale

TN= Aphthaid immunocompromised patients. Conklin Hall

Farmingdale NY 11735

DD= 6/29/99 MA=

Lactobin Treatment of AIDS-associated Roxane Laboratories, Inc.

diarrhea unresponsive to initial P.O. Box 16532

TN= Lactobin antidiarrheal therapy. Columbus OH 43216-6532

DD= 9/12/90 MA=

Lamotrigine Treatment of Lennox-Gastaut Glaxo Wellcome Research and

syndrome. 5 Moore Drive

TN= Lamictal P.O. Box 13398

Research Triangle Park NC 27709

DD= 8/23/95 MA= 8/24/98

Lanreotide, Somatostatin Treatment for acromegly IPSEN, Inc.

27 Maple Street

TN= Ipstyl Milford MA 01757

DD= 9/11/00 MA=

Leflunomide Prevention of acute and chronic Williams, MD, James W.

rejection in patients who have Rush-Presbyterian-St. Luke\'s

TN= received solid organ transplants. 1653 West Congress Parkway

Chicago IL 60612-3833

DD= 10/18/96 MA=

Lepirudin Treatment of heparin-associated Hoechst Marion Roussel

thrombocytopenia type II. Frankfurt am Main

TN= Refluden Germany DE

DD= 2/13/97 MA= 3/6/98

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Leucovorin For rescue use after high dose Immunex Corporation

methotrexate therapy in the 51 University Street

TN= Leucovorin calcium treatment of osteosarcoma. Seattle WA 98101

DD= 8/17/88 MA= 8/31/88

Leucovorin For use in combination with Immunex Corporation

5-fluorouracil for the treatment of 51 University Street

TN= Leucovorin calcium metastatic colorectal cancer. Seattle WA 98101

DD= 12/8/86 MA= 12/12/91

Leucovorin calcium For use in combination with Glaxo Wellcome Research
and

5-fluorouracil for the treatment of 5 Moore Drive

TN= Wellcovorin metastatic colorectal cancer. PO Box 13398

Research Triangle Park NC 27709

DD= 6/23/88 MA=

Leupeptin For use as an adjunct to Neuromuscular Adjuncts, Inc.

microsurgical peripheral nerve S.U.N.Y. at Stony Brook

TN= repair. H.S.C. T18-020

Stony Brook NY 11794-8181

DD= 9/18/90 MA=

Leuprolide acetate Treatment of central precocious Tap Pharmaceuticals,
Inc.

puberty. 2355 Waukegan Road

TN= Lupron Injection Deerfield IL 60015

DD= 7/25/88 MA= 4/16/93

Levocabastine HCl Treatment of vernal Iolab Pharmaceuticals

ophthalmic suspension keratoconjunctivitis. 500 Iolab Drive

TN= Claremont CA 94608

DD= 2/29/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Levocarnitine Treatment of zidovudine-induced Sigma-Tau Pharmaceuticals,
Inc.

mitochondrial myopathy. 800 S. Frederick Avenue, Suite

TN= Carnitor Gaithersburg MD 20877

DD= 4/7/97 MA=

Levocarnitine Treatment of primary and secondary Sigma-Tau
Pharmaceuticals, Inc.

carnitine deficiency of genetic 800 South Frederick Avenue

TN= Carnitor origin. Gaithersburg MD 20877

DD= 7/26/84 MA= 12/22/88

Levocarnitine Treatment of genetic carnitine Sigma-Tau Pharmaceuticals,
Inc.

deficiency. 800 South Frederick Avenue

TN= Carnitor Gaithersburg MD 20877

DD= 2/28/84 MA= 4/10/86

Levocarnitine Treatment of manifestations of Sigma-Tau Pharmaceuticals,
Inc.

carnitine deficiency in patients 800 South Frederick Avenue,

TN= Carnitor with end stage renal disease who Gaithersburg MD 20877

require dialysis.

DD= 9/6/88 MA= 12/15/99

Levocarnitine Treatment of pediatric Sigma-Tau Pharmaceuticals, Inc.

cardiomyopathy. 800 South Frederick Avenue

TN= Carnitor Gaithersburg MD 20877

DD= 11/22/93 MA=

Levocarnitine For the prevention of secondary Sigma-Tau Pharmaceuticals,
Inc.

carnitine deficiency in valproic 800 South Frederick Avenue

TN= Carnitor acid toxicity. Gaithersburg MD 20877

DD= 11/15/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Levocarnitine For the treatment of secondary Sigma-Tau Pharmaceuticals,
Inc.

carnitine deficiency in valproic 800 South Frederick Avenue

TN= Carnitor acid toxicity. Gaithersburg MD 20877

DD= 11/15/89 MA=

Levocarnitine Treatment of manifestations of Sigma-Tau Pharmaceuticals,
Inc.

carnitine deficiency in patients 800 South Frederick Avenue

TN= Carnitor with end stage renal disease who Gaithersburg MD 20877

require dialysis.

DD= 11/24/86 MA=

Levodopa and carbidopa Treatment of late stage Parkinson\'s Nouvel
Pharma, Inc.

disease. 11322 Acuff La.

TN= Duodopa Lenexa KS 66215

DD= 1/18/00 MA=

Levomethadyl acetate Treatment of heroin addicts Biodevelopment
Corporation

hydrochloride suitable for maintenance on opiate 8180 Greensboro Drive,
Suite

TN= Orlaam agonists. McLean VA 22102

DD= 1/24/84 MA= 7/9/93

Lidocaine patch 5% For relief of allodynia (painful Teikoku Pharma USA,
Inc.

hypersensitivity), and chronic pain 745-D Camden Ave.

TN= Lidoderm Patch in post-herpetic neuralgia. Campbell CA 95008-4146

DD= 10/24/95 MA= 3/19/99

Liothyronine sodium Treatment of myxedema coma/precoma. SmithKline
Beecham

injection One Franklin Plaza

TN= Triostat P.O. Box 7929

Philadelphia PA 19101

DD= 7/30/90 MA= 12/31/91

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Lipid/DNA human cystic Treatment of cystic fibrosis. Genzyme Corporation

fibrosis gene One Mountain Road

TN= P.O. Box 9322

Framingham MA 01701-9322

DD= 4/8/96 MA=

Liposomal amphotericin B Treatment of cryptococcal Fujisawa USA, Inc.

meningitis. 3 Parkway North Center

TN= AmBisome Deerfield IL 60015

DD= 12/10/96 MA= 8/11/97

Liposomal amphotericin B Treatment of visceral Fujisawa USA, Inc.

leishmaniasis. 3 Parkway North Center

TN= AmBisome Deerfield IL 60015

DD= 12/6/96 MA= 8/11/97

Liposomal amphotericin B Treatment of histoplasmosis. Fujisawa USA, Inc.

3 Parkway North Center

TN= AmBisome Deerfield IL 60015

DD= 12/10/96 MA=

Liposomal cyclosporin A For aerosolized administration in Vernon Knight,
M.D.

the prevention and treatment of Baylor College of Medicine,

TN= Cyclospire lung allograft rejection One Baylor Plaza

and pulmonary rejection events

associated with bone marrow Houston TX 77030

transplantation.

DD= 4/30/98 MA=

Liposomal Treatment of osteosarcoma. Endorex Corp.

N-Acetylglucosminyl-N-Ac 900 North Shore Drive

TN= ImmTher Lake Bluff IL 60044

DD= 6/10/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Liposomal Treatment of Ewing\'s sarcoma. Endorex Corp.

N-Acetylglucosminyl-N-Ac 900 North Shore Drive

TN= ImmTher Lake Bluff IL 60044

DD= 6/10/98 MA=

Liposomal nystatin Treatment of invasive fungal Aronex Pharmaceuticals,
Inc.

infections. 8707 Technology Forest Place

TN= Nyotran The Woodlands TX 77381-1191

DD= 6/13/00 MA=

Liposomal prostaglandin Treatment of acute respiratory Liposome Company,
Inc.

E1 injection distress syndrome. One Research Way

TN= Princeton NJ 08540

DD= 4/25/96 MA=

Liposomal-cis-bis-neodec Treatment of malignant Aronex Pharmaceuticals,
Inc.

anoato-trans-R,R-1,2-dia mesothelioma. 8707 Technolgoy Forest Place

TN= The Woodlands TX 77381

DD= 9/1/99 MA=

Liposome encapsulated Treatment of cancers of the kidney Biomira USA,
Inc.

recombinant and renal pelvis. 1002 Eastpark Boulevard

TN= Cranbury NJ 08512

DD= 6/20/94 MA=

Liposome encapsulated Treatment of brain and CNS tumors. Biomira USA,
Inc.

recombinant 1002 Eastpark Boulevard

TN= Cranbury NJ 08512

DD= 11/25/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Lisofylline Treatment of patients undergoing Cell Therapeutics, Inc.

induction therapy for acute myeloid 201 Elliot Ave. W., Suite 400

TN= leukemia. Seattle WA 98119

DD= 6/10/99 MA=

Lodoxamide tromethamine Treatment of vernal Alcon Laboratories, Inc.

keratoconjunctivitis. 6201 South Freeway

TN= Alomide Ophthalmic Fort Worth TX 76134

DD= 10/16/91 MA= 9/23/93

Loxoribine Treatment of common variable R. W. Johnson Pharmaceutical

immunodeficiency. Route 202, P.O. Box 300

TN= Raritan NJ 08869

DD= 2/24/92 MA=

Lucinactant Treatment of acute respiratory Discovery Laboratories, Inc.

distress syndrome in adults. 350 South Main Street

TN= Surfaxin Suite 307

Doylestown PA 18901

DD= 7/17/95 MA=

Lucinactant Treatment of respiratory distress Discovery Laboratories,
Inc.

syndrome in premature infants. 350 South Main Street

TN= Surfaxin Suite 307

Doylestown PA 18901

DD= 10/18/95 MA=

Lucinactant Treatment of meconium aspiration Discovery Laboratories,
Inc.

syndrome in newborn infants. 350 South Main Street

TN= Surfaxin Suite 307

Doylestown PA 18901

DD= 7/30/96 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Lysine acetylsalicylate Treatment of pain and fever G.D. Searle &
Company

injectable secondary to sickle cell disease

TN= crisis.

DD= 8/1/89 MA=

Mafenide acetate For use as an adjunctive topical Mylan Laboratories,
Inc.

solution antimicrobial agent to control 781 Chestnut Ridge Road

TN= Sulfamylon solution bacterial infection when used under P.O. Box
4310

moist dressings over meshed

autografts on excised burn wounds. Morgantown WV 26504-4310

DD= 7/18/90 MA= 6/5/98

Marijuana Treatment of HIV-associated wasting Multidisciplinary
Association

syndrome. 3 Francis St.

TN= Belmont MA 02478

DD= 5/25/99 MA=

MART-1 adenoviral gene Treatment of metastatic melanoma. Genzyme
Corporation

therapy for malignant One Mountain Road

TN= P.O. Box 9322

Framingham MA 01701-9322

DD= 3/28/97 MA=

Matrix metalloproteinase Treatment of corneal ulcers. Glycomed, Inc

inhibitor 860 Atlantic Avenue

TN= Galardin Alameda CA 94501

DD= 12/5/91 MA=

Mazindol Treatment of Duchenne muscular Collipp, Platon J. M.D.

dystrophy. 176 Memorial Drive

TN= Sanorex Jesup GA 31545

DD= 12/8/86 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Mecamylamine Treatment of Tourette\'s syndrome. Layton Bioscience, Inc.

105 Reservoir Rd.

TN= Inversine Atherton CA 94027

DD= 10/14/98 MA=

Mecasermin Treatment of growth hormone Genentech, Inc.

insufficency syndrome. 460 Point San Bruno Boulevard

TN= South San Francisco CA 94080

DD= 12/12/95 MA=

Mecasermin Treatment of amyotrophic lateral Cephalon, Inc.

sclerosis. 145 Brandywine Parkway

TN= Myotrophin West Chester PA 19380-4245

DD= 8/5/91 MA=

Mefloquine HCl Treatment of acute malaria due to Hoffmann-La Roche, Inc.

Plasmodium falciparum and 340 Kingsland Street

TN= Lariam Plasmodium vivax. Nutley NJ 07110

DD= 4/13/88 MA= 5/2/89

Mefloquine HCl Treatment of chloroquine-resistant Mepha AG

Falciparummalaria. 4143 Dornach

TN= Mephaquin POSTFASH 137

Aesch Basel, Switzerland CH

DD= 7/22/87 MA=

Mefloquine HCl Prevention of chloroquine-resistant Mepha AG

Falciparum malaria. 4143 Dornach

TN= Mephaquin POSTFASH 137

Aesch Basel, Switzerland CH

DD= 7/22/87 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Mefloquine HCl Prophylaxis of Plasmodium Hoffmann-La Roche, Inc.

falciparum malaria which is 340 Kingsland Street

TN= Lariam resistant to other available drugs. Nutley NJ 07110

DD= 4/13/88 MA= 5/2/89

Megestrol acetate Treatment of patients with Bristol-Myers Squibb

anorexia, cachexia, or significant 2400 West Lloyd Expressway

TN= Megace weight loss (=/\>10% of baseline Evansville IN 47721

body weight) and confirmed

diagnosis of AIDS.

DD= 4/13/88 MA= 9/10/93

Melanoma cell vaccine Treatment of invasive melanoma. Morton, Donald L.
M.D.

John Wayne Cancer Institute

TN= 2200 Santa Monica Boulevard

Santa Monica CA 90404

DD= 10/13/94 MA=

Melanoma vaccine Treatment of stage III - IV Ribi ImmunoChem Research,
Inc.

melanoma. 533 Old Corvallis Road

TN= Melacine Hamilton MT 59840

DD= 12/20/89 MA=

Melatonin Treatment of circadian rhythm sleep Sack, Robert, M.D.

disorders in blind people with no Oregon Health Sciences

TN= light perception. 3181 S.W. Sam Jackson Park Road

Portland OR 97201

DD= 11/15/93 MA=

Melphalan Treatment of patients with multiple Glaxo Wellcome Inc.

myeloma for whom oral therapy is 5 Moore Drive

TN= Alkeran For inappropriate. Research Triangle Park NC 27709

DD= 2/24/92 MA= 11/18/92

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Melphalan For use in hyperthermic regional Glaxo Wellcome Research and

limb perfusion to treat metastatic 5 Moore Drive

TN= Alkeran for melanoma of the extremity. PO Box 13398

Research Triangle Park NC 27709

DD= 3/3/92 MA=

Meropenem Management of acute pulmonary Zeneca Pharmaceuticals

exacerbations, in cystic fibrosis 1800 Concord Pike

TN= Merrem IV patients, due to respiratory tract PO Box 15437

infection with susceptible

organisms. Wilmington DE 19850-5437

DD= 4/27/00 MA=

Mesna Inhibition of the urotoxic effects Asta Medica , Inc.

induced by oxazaphosphorine 890 East St.

TN= compounds such as cyclophosphamide. Tewksbury MA 01876-1496

DD= 12/16/87 MA=

Mesna For use as a prophylactic agent in Degussa Corporation

reducing the incidence of 65 Challenger Road

TN= Mesnex ifosfamide-induced hemorrhagic Ridgefield Park NJ 07660

cystitis.

DD= 11/14/85 MA= 12/30/88

Methionine/L-methionine Treatment of AIDS myelopathy. Di Rocco,
Alessandro M.D.

Beth Israel Medical Center,

TN= Philips Building, Suite 2R; 10

New York NY 10003

DD= 8/21/96 MA=

Methotrexate Treatment of juvenile rheumatoid Wyeth-Ayerst Laboratories

arthritis. P.O. Box 8299

TN= Rheumatrex Philadelphia PA 19101-8299

DD= 8/23/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Methotrexate sodium Treatment of osteogenic sarcoma. Lederle
Laboratories

Division of American Cyanamid

TN= Methotrexate 401 N. Middletown Road

Pearl River NY 10965

DD= 10/21/85 MA= 4/7/88

Methotrexate with Topical treatment of mycosis Durham Pharmaceuticals
LLC

laurocapram fungoides. 200 Westpark Corporate Center

TN= Methotrexate/azone 4364 South Alston Avenue

Durham NC 27713-2280

DD= 10/15/90 MA=

Methoxsalen For use in conjunction with the Therakos, Inc.

UVAR photopheresis system to treat 437 Creamery Way

TN= Uvadex graft versus host disease. Exton PA 19431

DD= 10/14/98 MA=

Methylnaltrexone Treatment of chronic opioid-induced University of
Chicago

constipation unresponsive to 5841 South Maryland Avenue

TN= conventional therapy. MC 4028

Chicago IL 60637

DD= 6/17/96 MA=

Metronidazole Treatment of perioral dermatitis. Galderma Laboratories,
Inc.

P.O. Box 331329

TN= Metrogel Fort Worth TX 76163

DD= 10/24/91 MA=

Metronidazole (topical) Treatment of acne rosacea. Galderma
Laboratories, Inc.

P.O. Box 331329

TN= Metrogel Fort Worth TX 76163

DD= 10/22/87 MA= 11/22/88

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Metronidazole (topical) Treatment of grade III and IV, Searle

anaerobically infected, decubitus 4901 Searle Parkway

TN= Flagyl ulcers. Skokie IL 60077

DD= 11/24/87 MA=

Microbubble contrast Intraoperative aid in the Cav-Con, Inc.

agent identification and localization of 55 Knollwood Road

TN= Filmix intracranial tumors. Farmington CT 06032

DD= 11/16/90 MA=

Midodrine HCl Treatment of patients with Schier Ridgewood F.K.A.

symptomatic orthostatic Meridian Center III

TN= Amatine hypotension. 6 Industrial Way West

Eatontown NJ 07724

DD= 12/5/96 MA= 9/6/96

Minocycline HCl Treatment of chronic malignant Lederle Laboratories
Division

pleural effusion.

TN= Minocin Intravenous Pearl River NY 10965

DD= 6/19/92 MA=

Mitoguazone Treatment of diffuse non-Hodgkin\'s ILEX Oncology, Inc.

lymphoma, including AIDS-related 4545 Horizon Hill Blvd.

TN= Zyrkamine diffuse non-Hodgkin\'s lymphoma. San Antonio TX 78229-2263

DD= 3/18/94 MA=

Mitolactol As adjuvant therapy in the Biopharmaceutics, Inc.

treatment of primary brain tumors. 990 Station Road

TN= Bellport NY 11713

DD= 7/12/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Mitolactol Treatment of recurrent invasive or Biopharmaceutics, Inc.

metastatic squamous carcinoma of 990 Station Road

TN= the cervix. Bellport NY 11713

DD= 1/23/89 MA=

Mitomycin-C Treatment of refractory glaucoma as IOP Inc.

an adjunct to ab externo glaucoma 3100 Airway Avenue, Suite 106

TN= surgery. Costa Mesa CA 92626

DD= 8/20/93 MA=

Mitoxantrone Treatment of secondary-progressive Immunex Corporation

multiple sclerosis. 51 University St.

TN= Novantrone Seattle WA 98101

DD= 8/13/99 MA= 10/13/00

Mitoxantrone Treatment of progressive-relapsing Immunex Corporation

multiple sclerosis. 51 University St.

TN= Novantrone Seattle WA 98101

DD= 8/13/99 MA= 10/13/00

Mitoxantrone Treatment of hormone refractory Immunex Corporation

prostate cancer. 51 University Street

TN= Novantrone Seattle WA 98101

DD= 8/21/96 MA= 11/13/96

Mitoxantrone HCl Treatment of acute myelogenous Lederle Laboratories

leukemia, also referred to as acute Division of American Cyanamid

TN= Novantrone nonlymphocytic leukemia. 401 N. Middletown Road

Pearl River NY 10965

DD= 7/13/87 MA= 12/23/87

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

MN14 monoclonal antibody Treatment of pancreatic cancer. Immunomedics,
Inc.

to carcinoembryonic 300 American Road

TN= Cea-Cide Morris Plains NJ 07950

DD= 11/24/98 MA=

MN14 monoclonal antibody For the treatment of small cell Immunomedics,
Inc.

to carcinoembryonic lung cancer. 300 American Rd.

TN= Cea-Cide Morris Plains NJ 07950

DD= 9/18/98 MA=

Modafinil Treatment of excessive daytime Cephalon, Inc.

sleepiness in narcolepsy. 145 Brandywine Parkway

TN= Provigil West Chester PA 19380

DD= 3/15/93 MA= 12/24/98

Molgramostim Treatment of AIDS patients with Schering Corporation

neutropenia due to the disease, 2000 Galloping Hill Road

TN= Leucomax AZTor ganciclovir. Kenilworth NJ 07033

DD= 1/24/89 MA=

Molgramostim Treatment of aplastic anemia. Schering Corporation

2000 Galloping Hill Road

TN= Leucomax Kenilworth NJ 07033

DD= 9/25/89 MA=

Monoclonal Ab(murine) Treatment of invasive cutaneous IDEC
Pharmaceuticals Corporation

anti-idiotype melanoma. 3030 Callan Road

TN= Melimmune San Diego CA 92121

DD= 9/19/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Monoclonal antibodies Treatment of B-cell lymphoma. IDEC Pharmaceuticals
Corporation

(murine or human) to 11011 Torreyana Road

TN= San Diego CA 92121

DD= 5/6/86 MA=

Monoclonal antibodies For the exogenous depletion of CD14 Medarex, Inc.

PM-81 and AML-2-23 and CD15 positive acute myeloid 67 Beaver Avenue

TN= leukemic bone marrow cells from Annandale NJ 08801-0953

patients undergoing bone marrow

transplantation.

DD= 3/12/90 MA=

Monoclonal antibody Treatment of pancreatic cancer. Centocor, Inc.

17-1a 244 Great Valley Parkway

TN= Panorex Malvern PA 19355

DD= 4/4/88 MA=

Monoclonal antibody for Treatment of lupus nephritis. VivoRx Autoimmune,
Inc.

immunization against 2825 Santa Monica Blvd., Suite

TN= Santa Monica CA 90404

DD= 1/7/93 MA=

Monoclonal antibody Adjunctive treatment of acute Medarex, Inc.

PM-81 myelogenous leukemia. 67 Beaver Avenue

TN= Annandale NJ 08801

DD= 6/27/91 MA=

Monoclonal antibody to Prophylaxis of cytomegalovirus Protein Design
Labs, Inc.

cytomegalovirus (human) disease in patients undergoing 2375 Garcia
Avenue

TN= solid organ transplantation. Mountain View CA 94043

DD= 9/13/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Monoclonal antibody to Treatment of cytomegalovirus Protein Design Labs,
Inc.

cytomegalovirus (human) retinitis in patients with AIDS. 2375 Garcia
Avenue

TN= Mountain View CA 94043

DD= 11/15/91 MA=

Monoclonal antibody to Prophylaxis of hepatitis B Protein Design Labs,
Inc.

hepatitis B virus reinfection in patients undergoing 34801 Campus Dr.

TN= liver transplantation secondary to Fremont CA 94555

end-stage chronic hepatitis B

infection.

DD= 6/17/91 MA=

Monoclonal Treatment of epithelial ovarian AltaRex US Corp.

antibody-B43.13 cancer. 610 Lincoln Street

TN= Ovarex MAb-B43.13 Waltham MA 02451

DD= 11/25/96 MA=

Monoclonal antiendotoxin Treatment of patients with Pfizer, Inc.

antibody XMMEn-0e5 gram-negative sepsis which has 235 East 42nd Street

TN= progressed to shock. New York NY 10017

DD= 11/4/85 MA=

Monolaurin Treatment of congenital primary Glaxo Wellcome Inc.

ichthyosis. 5 Moore Drive

TN= Glylorin PO Box 13398

Research Triangle Park NC 27709

DD= 4/29/93 MA=

Monooctanoin For dissolution of cholesterol Ethitek Pharmaceuticals,
Inc.

gallstones retained in the common 7855 Gross Point Road, Unit L

TN= Moctanin bile duct. Skokie IL 60077

DD= 5/30/84 MA= 10/31/85

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Morphine sulfate For use in microinfusion devices Elkins-Sinn, Inc.

concentrate for intraspinal administration in 2 Esterbrook Lane

TN= Infumorph the treatment of intractable Cherry Hill NJ 08003

chronic pain.

DD= 7/12/90 MA= 7/19/91

MTC-DOX for Injection Treatment of hepatocellular FeRx Incorporated

carcinoma 4330 La Jolla Village Drive

TN= Suite #250

San Diego CA 92122

DD= 1/3/01 MA=

Mucoid exopolysaccharide Treatment of pulmonary infections North
American Biologicals, Inc.

Pseudomonas hyperimmune due to Pseudomonas aeruginosa in 12280 Wilkins
Avenue

TN= MEP IGIV patients with cystic fibrosis. Rockville MD 20852

DD= 1/9/91 MA=

Mucoid exopolysaccharide Prevention of pulmonary infections North
American Biologicals, Inc.

Pseudomonas hyperimmune due to Pseudomonas aeruginosa in 12280 Wilkins
Avenue

TN= MEP IGIV patients with cystic fibrosis. Rockville MD 20852

DD= 11/7/90 MA=

Multi-vitamin infusion For establishment and maintenance Astra
Pharmaceuticals, L.P.

(neonatal formula) of total parenteral nutrition in 725 Chesterbrook
Blvd.

TN= very low birth weight infants. Wayne PA 19087-5677

DD= 12/12/89 MA=

Murine MAb (Lym-1) and Treatment of B-cell non-Hodgkin\'s Berlex
Laboratories

Iodine 131-I lymphoma. 15049 San Pablo Ave.

TN= Oncolym PO Box 4099

Richmond CA 94804-0099

DD= 11/27/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Murine MAb to Adjuvant treatment of ovarian Antisoma plc

polymorphic epithelial cancer. West Africa House

TN= Theragyn Hanger Lane Ealing

London W5 3QR UK

DD= 3/22/99 MA=

Mycobacterium avium For use in the diagnosis of Statens Seruminstitut

sensitin RS-10 invasive Mycobacterium avium 5 Artillerivej

TN= disease in immunocompetent DK-2300 Copenhagen S

individuals.

Denmark

DD= 10/11/95 MA=

Myelin Treatment of multiple sclerosis. AutoImmune, Inc.

128 Spring Street

TN= Lexington MA 02173

DD= 6/27/91 MA=

N-acetyl-procainamide Prevention of life-threatening NAPA of the Bahamas

ventricular arrhythmias in patients 3560 Pennsylvania Avenue, Suite

TN= with documented Dubuque IA 52002

procainamide-induced lupus.

DD= 12/10/96 MA=

N-acetylcysteinate For the management of cystic Galephar Pharmaceutical

fibrosis Road 198, No. 100 km. 14.7

TN= Nacystelyn Dry Juncos Industrial Park

Juncos PR 00777-3873

DD= 12/27/00 MA=

N-acetylgalactosamine-4- Treatment of mucopolysaccharidosis BioMarin
Pharmaceutical, Inc.

sulfatase, recombinant Type VI (Maroteaux-Lamy syndrome). 11 Pimental
Court

TN= Novato CA 94949-5608

DD= 2/17/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

N-acetylprocainamide To lower the defibrillation energy Medco Research,
Inc.

requirement sufficiently to allow 8455 Beverly Blvd.

TN= Napa automatic implantable cardioverter Suite 308

defibrillator therapy in those

patients who could otherwise not Los Angeles CA 90048

use the device.

DD= 3/23/90 MA=

Nafarelin acetate Treatment of central precocious Syntex (USA), Inc.

puberty. 3401 Hillview Avenue

TN= Synarel Nasal Palo Alto CA 94303

DD= 7/20/88 MA= 2/26/92

Naltrexone HCl For blockade of the pharmacological DuPont
Pharmaceuticals

effects of exogenously E.I. Du Pont De Nemours & Co.

TN= Trexan administered opioids as an adjunct Wilmington DE 19880

to the maintenance of the

opioid-free state in detoxified

formerly opioid-dependent

DD= 3/11/85 MA= 11/30/84

Natural human Treatment of Behcet\'s disease. Amarillo Biosciences, Inc.

lymphoblastoid 800 West Ninth Avenue

TN= Amarillo TX 79101-3206

DD= 1/18/00 MA=

Natural human Treatment of papillomavirus warts Amarillo Biosciences.
Inc.

lymphoblastoid in the oral cavity of HIV positive 800 West 9th Avenue

TN= patients. Amarillo TX 79101

DD= 8/10/00 MA=

NDROGE Treatment of postanoxic intention WATSON Laboratories, Inc.

myoclonus. 33 Ralph Avenue

TN= P.O. Box 30

Copiaque NY 11726-0030

DD= 11/1/84 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Nebacumab Treatment of patients with Centocor, Inc.

gram-negative bacteremia which has 200 Great Valley Parkway

TN= Centoxin progressed to endotoxin shock. Malvern PA 19355

DD= 10/1/86 MA=

Neurotrophin-1 Treatment of motor neuron Ericsson, Arthur Dale, M.D.

disease/amyotrophic lateral 6560 Fannin, Scurlock Tower,

TN= sclerosis. Houston TX 77303

DD= 9/13/94 MA=

NG-29 Diagnostic measure of the capacity Ferring Laboratories, Inc.

of the pituitary gland to release 400 Rella Boulevard, Suite 201

TN= Somatrel growth hormone. Suffern NY 10901

DD= 8/8/89 MA=

Nifedipine Treatment of interstitial cystitis. Fleischmann, Jonathan
M.D.

MetroHealth Medical Center

TN= 3395 Scranton Road

Cleveland OH 44109

DD= 6/13/91 MA=

Nitazoxanide Treatment of immunocompromised Romark Laboratories, L.C.

patients with cryptosporidiosis. 6200 Courtney Campbell Causeway

TN= Cryptaz Suite 880

Tampa FL 33607

DD= 12/12/96 MA=

Nitisinone Treatment of tyrosinemia type 1. Swedish Orphan AB

Drottninggatan 98

TN= Orfadin SE-111 60 Stockholm

Sweden SE

DD= 5/16/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Nitric oxide Treatment of persistent pulmonary INO Therapeutics, Inc.

hypertension in the newborn. 54 Old Highway 22

TN= INOmax Clinton NJ 08809

DD= 6/22/93 MA= 12/23/99

Nitric oxide Treatment of acute respiratory INO Therapeutics, Inc.

distress syndrome in adults. 54 Old Highway 22

TN= Clinton NJ 08809

DD= 7/10/95 MA=

Novel Acting Treatment of peripheral arterial Amgen, Inc.

Thrombolytic (NAT) occlusion (PAO) One Amgen Center Drive

TN= Thousand Oaks CA 91320-1799

DD= 1/26/01 MA=

Octreotide Treatment of severe diarrhea and Novartis Pharmaceuticals

flushing associated with malignant 59 Route 10

TN= Sandostatin LAR carcinoid tumors. East Hanover NJ 07936-1080

DD= 8/24/98 MA= 11/25/98

Octreotide Treatment of diarrhea associated Novartis Pharmaceuticals

with vasoactive intestinal peptide 59 Route 10

TN= Sandostatin LAR tumors (VIPoma). East Hanover NJ 07936-1080

DD= 8/24/98 MA= 11/25/98

Octreotide Treatment of acromegaly. Novartis Pharmaceuticals

59 Route 10

TN= Sandostatin LAR East Hanover NJ 07936-1080

DD= 8/24/98 MA= 11/25/98

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ofloxacin Treatment of bacterial corneal Allergan, Inc.

ulcers. 2525 Dupont Drive

TN= Ocuflox Ophthalmic P.O. Box 19534

Irvine CA 92713

DD= 4/18/91 MA= 5/22/96

OM 401 Prophylactic treatment of sickle Omex International, Inc.

cell disease. 6001 Savoy, Suite 110

TN= Drepanol Houston TX 77036

DD= 10/24/91 MA=

Omega-3 (n-3) Prevention of organ graft Research Triangle

polyunsaturated fatty rejection. 4364 South Alston Avenue

TN= Durham NC 27713

DD= 11/22/95 MA=

Omega-3 (n-3) Treatment of IgA nephropathy. Pronova Biocare, AS

polyunsaturated fatty PO Box 420

TN= Omacor 1327 Lysaker

Norway

DD= 5/4/00 MA=

Oncorad Ov103 Treatment of ovarian cancer. Cytogen Corporation

600 College Road East

TN= Princeton NJ 08540

DD= 4/24/90 MA=

Oprelvekin Prevention of severe Genetics Institute, Inc.

chemotherapy-induced 87 Cambridge Park Drive

TN= Neumega Cambridge MA 02140

DD= 12/17/96 MA= 11/25/97

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Orgotein for injection Treatment of familial amyotrophic Oxis
International, Inc.

lateral sclerosis associated with a 6040 N. Cutter Circle, Suite 317

TN= mutation of the gene (on Portland OR 97217-3935

chromosome 21q) for copper, zinc

superoxide dismutase.

DD= 12/22/94 MA=

Oxaliplatin Treatment of ovarian cancer. Debio Pharm S.A.

Rue des Terreaux 17

TN= CH-1000

Lausanne 9 Switzerland CH

DD= 10/6/92 MA=

Oxandrolone Adjunctive therapy for AIDS Bio-Technology General Corp.

patients suffering from HIV-wasting 70 Wood Avenue, South

TN= Oxandrin syndrome. Iselin NJ 08830

DD= 9/6/91 MA=

Oxandrolone Treatment of moderate/severe acute Bio-Technology General
Corp.

alcoholic hepatitis in the presence 70 Wood Avenue South

TN= Hepandrin of moderate protein calorie Iselin NJ 08830

malnutrition.

DD= 3/18/94 MA=

Oxandrolone Treatment of patients with Bio-Technology General Corp.

Duchenne\'s muscular dystrophy and 70 Wood Avenue South

TN= Oxandrin Becker\'s muscular dystrophy. Iselin NJ 08830

DD= 4/22/97 MA=

Oxandrolone Treatment of constitutional delay Bio-Technology General
Corp.

of growth and puberty. 70 Wood Avenue, South

TN= Iselin NJ 08830

DD= 10/5/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Oxandrolone Treatment of short stature Bio-Technology General Corp.

associated with Turner\'s syndrome. 70 Wood Avenue, South

TN= Oxandrin Iselin NJ 08830

DD= 7/5/90 MA=

Oxybate Treatment of narcolepsy. Orphan Medical, Inc.

13911 Ridgedale Drive

TN= Xyrem Suite 250

Minnetonka MN 55305

DD= 11/7/94 MA=

Oxymorphone For relief of severe intractable DuPont Merck Pharmaceutical

pain in narcotic-tolerant patients. P.O. Box 80027

TN= Numorphan H.P. Wilmington DE 19880

DD= 3/19/85 MA=

Oxypurinol Treatment of hyperuricemia in ILEX Oncology, Inc.

patients intolerant to allopurinol. 4545 Horizon Hill Blvd.

TN= San Antonio TX 78229-2263

DD= 11/9/98 MA=

P1, P4-Di(uridine Treatment of cystic fibrosis. Inspire Pharmaceuticals,
Inc.

5\'-tetraphosphate), 4222 Emperor Blvd., Suite 470

TN= Durham NC 27703

DD= 10/27/98 MA=

Paclitaxel Treatment of AIDS-related Kaposi\'s Bristol-Myers Squibb

sarcoma. 5 Research Parkway

TN= Taxol P.O. Box 5100

Wallingford CT 06492-7660

DD= 3/25/97 MA= 8/4/97

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Paclitaxel Treatment of AIDS-related Kaposi\'s Baker Norton
Pharmaceuticals,

sarcoma. 4400 Biscayne Boulevard

TN= Paxene Miami FL 33137

DD= 4/15/97 MA=

Papain, trypsin, and Treatment of multiple myeloma. Marlyn
Nutraceuticals, Inc.

chymotrypsin 14851 N. Scottsdale Rd.

TN= Wobe-Mugos Scottsdale AZ 85254

DD= 12/21/98 MA=

Papaverine topical gel Treatment of sexual dysfunction in Pharmedic
Company

spinal cord injury patients. 417 Harvester Court

TN= Wheeling IL 60090

DD= 2/6/92 MA=

Parovirus B19 Prevention of transient aplastic MedImmune, Inc.

(recombinant VP1 and crisis in patients with sickle cell 35 West Watkins
Mill Rd.

TN= MEDI-491 anemia. Gaithersburg MD 20878

DD= 5/7/99 MA=

Patul-end Treatment of patulous eustachian Ear Foundation

tube. 2420 Castillo Street, Suite 100

TN= Santa Barbara CA 93105

DD= 2/18/97 MA=

PEG-glucocerebrosidase For use as chronic enzyme National Institute of
Mental

replacement therapy in patients 49 Convent Dr. MSC4405

TN= Lysodase with Gaucher\'s disease who are Bldg. 49, Room B1EE16

deficient in glucocerebrosidase.

Bethesda MD 20892-4405

DD= 12/9/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

PEG-interleukin-2 Treatment of primary Chiron Corporation

immunodeficiencies associated with 4560 Horton Street

TN= T-cell defects. Emeryville CA 94608

DD= 2/1/90 MA=

Pegademase bovine For enzyme replacement therapy for Enzon, Inc.

ADA deficiency in patients with 20 Kingsbridge Road

TN= Adagen severe combined immunodeficiency. Piscataway NJ 08854

DD= 5/29/84 MA= 3/21/90

Pegaspargase Treatment of acute lymphocytic Enzon, Inc.

leukemia. 20 Kingsbridge Road

TN= Oncaspar Piscataway NJ 08854

DD= 10/20/89 MA= 2/1/94

Peginterferon alfa-2a Treatment of renal cell carcinoma. Hoffman-La
Roche Inc.

340 Kingsland St.

TN= PEGASYS Nutley NJ 07110-1199

DD= 7/13/98 MA=

Peginterferon alfa-2a Treatment of chronic myelogenous Hoffman-La Roche
Inc.

leukemia. 340 Kingsland St.

TN= PEGASYS Nutley NJ 07110-1199

DD= 9/30/99 MA=

Pegylated arginine Treatment of invasive malignant Phoenix
Pharmacologics, Inc.

deiminase melanoma. 115 John Robert Thomas Dr.

TN= Melanocid Exton PA 19341

DD= 4/12/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Pegylated arginine Treatment of hepatocellular Phoenix Pharmacologics,
Inc.

deiminase carcinoma. 115 John Robert Thomas Dr.

TN= Hepacid Exton PA 19341

DD= 3/26/99 MA=

Pegylated recombinant For reducing the period of Amgen, Inc.

human megakaryocyte thrombocytopenia in patients One Amgen Center Dr.

TN= MEGAGEN undergoing hematopoietic stem cell Thousand Oaks CA
91320-1789

transplantation.

DD= 10/20/97 MA=

Peldesine Treatment of cutaneous T-cell BioCryst Pharmaceuticals, Inc.

lymphoma. 2190 Parkway Lake Drive

TN= Birmingham AL 35244

DD= 10/5/93 MA=

Pentamidine isethionate Treatment of Pneumocystis carinii Fujisawa USA,
Inc.

pneumonia. 3 Parkway North Center

TN= Pentam 300 Deerfield IL 60015

DD= 2/28/84 MA= 10/16/84

Pentamidine isethionate Prevention of Pneumocystis carinii Fujisawa USA,
Inc.

pneumonia in patients at high risk 3 Parkway North Center

TN= Nebupent of developing this disease. Deerfield IL 60015

DD= 1/12/88 MA= 6/15/89

Pentamidine isethionate Treatment of Pneumocystis carinii Aventis
Behring L.L.C.

pneumonia. 1020 First Avenue

TN= PO Box 61501

King of Prussia PA 19406-0901

DD= 10/29/84 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Pentamidine isethionate Prevention of Pneumocystis carinii Fisons
Corporation

(inhalation) pneumonia in patients at high risk 755 Jefferson Rd., P.O.
Box 1710

TN= Pneumopent of developing this disease. Rochester NY 14603

DD= 10/5/87 MA=

Pentastarch As an adjunct in leukapheresis to Du Pont Pharmaceuticals

improve the harvesting and increase E.I. Du Pont De Nemours & Co.

TN= Pentaspan the yield of leukocytes by Wilmington DE 19898

centrifugal means.

DD= 8/28/85 MA= 5/19/87

Pentosan polysulfate Treatment of interstitial cystitis. Alza
Corporation

sodium 950 Page Mill Rd.

TN= Elmiron PO Box 10950

Palo Alto CA 94303-0802

DD= 8/7/85 MA= 9/26/96

Pentostatin Treatment of patients with chronic SuperGen, Inc.

lymphocytic leukemia. Two Annabel Lane

TN= Nipent Suite 220

San Ramon CA 94583

DD= 1/29/91 MA=

Pentostatin Treatment of cutaneous T-cell SuperGen, Inc.

lymphoma. Two Annbel Lane, Suite 220

TN= Nipent San Ramon CA 94583

DD= 3/27/98 MA=

Pentostatin Treatment of peripheral T-cell SuperGen, Inc.

lymphomas. Two Annabel Lane, Suite 220

TN= Nipent San Ramon CA 94583

DD= 11/24/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Pentostatin for Treatment of hairy cell leukemia. SuperGen, Inc.

injection Two Annabel Lane

TN= Nipent Suite 220

San Ramon CA 94583

DD= 9/10/87 MA= 10/11/91

Perfosfamide For use in the ex-vivo treatment of Scios Nova, Inc.

autologous bone marrow and 2450 Bayshore Parkway

TN= Pergamid subsequent reinfusion in patients Mountain View CA 94043

with acute myelogenous leukemia,

also referred to as acute

nonlymphocytic leukemia.

DD= 12/4/89 MA=

Pergolide Treatment of Tourette\'s syndrome. Sallee, Floyd R. M.D.,
Ph.D.

Medical University of South

TN= Permax 171 Ashley Avenue, Room PH246

Charleston SC 29425

DD= 11/20/97 MA=

Phenylacetate For use as an adjunct to surgery, Elan Pharmaceutical
Research

radiation therapy and chemotherapy 1300 Gould Dr.

TN= for the treatment of patients with Gainesville GA 30504

primary or recurrent malignant

glioma.

DD= 3/6/98 MA=

Phenylalanine Treatment of hyperphenylalaninemia. Ibex Technologies,
Inc.

ammonia-lyase 5485 Pare

TN= Phenylase Montreal, Quebec

Canada H4P 1P7 CA

DD= 3/8/95 MA=

Phenylbutyrate Treatment of acute promyelocytic Elan Corporation

leukemia. 1300 Gould Dr.

TN= Gainesville GA 30504

DD= 1/19/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Phosphocysteamine Treatment of cystinosis. Medea Research Laboratories

Port Jefferson Business Center

TN= 200 Wilson Street, Building D-6

Port Jefferson NY 11776

DD= 9/12/88 MA=

Pilocarpine Treatment of xerostomia induced by MGI Pharma, Inc.

radiation therapy for head and neck 6300 West Old Shakopee Rd.

TN= Salagen cancer. Suite 110

Bloomington MN 55438-2318

DD= 9/24/90 MA= 3/22/94

Pilocarpine HCl Treatment of xerostomia and MGI Pharma, Inc.

keratoconjunctivitis sicca in 6300 West Old Shakopee Rd.

TN= Salagen Sjogren\'s syndrome patients. Suite 110

Bloomington MN 55438-2318

DD= 2/28/92 MA= 2/11/98

Piracetam Treatment of myoclonus. UCB Pharma, Inc.

1950 Lake Park Drive

TN= Nootropil Smyrna GA 30080

DD= 10/2/87 MA=

Piritrexim isethionate Treatment of infections caused by Burroughs
Wellcome Company

Pneumocystis carinii, Toxoplasma 3030 Cornwallis Road

TN= gondii, and Mycobacterium P.O. Box 12700

avium-intracellulare.

Research Triangle Park NC 27709

DD= 6/13/88 MA=

Polifeprosan 20 with Treatment of malignant glioma. Guilford
Pharmaceuticals, Inc.

carmustine 6611 Tributary Street

TN= Gliadel Baltimore MD 21224

DD= 12/13/89 MA= 9/23/96

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Poloxamer 188 Treatment of vasospasm in CytRx Corporation

subarachnoid hemorrhage patients 154 Technology Parkway

TN= following surgical repair of a Norcross GA 30092

ruptured cerebral aneurysm.

DD= 8/5/97 MA=

Poloxamer 188 Treatment of severe burns requiring CytRx Corporation

hospitalization. 154 Technology Parkway

TN= Florcor Norcross GA 30092

DD= 2/22/90 MA=

Poloxamer 188 Treatment of sickle cell crisis. CytRx Corporation

154 Technology Parkway

TN= Flocor Norcross GA 30092

DD= 6/27/89 MA=

Poloxamer 331 Initial therapy of toxoplasmosis in CytRx Corporation

patients with AIDS. 154 Technology Parkway

TN= Protox Norcross GA 30092

DD= 3/21/91 MA=

Poly I: poly C12U Treatment of invasive metastatic Hemispherx Biopharma,
Inc.

melanoma (stage IIb, III, IV). One Penn Center

TN= Ampligen 1617 JFK Boulevard

Philadelphia PA 19103

DD= 12/9/93 MA=

Poly I: poly C12U Treatment of renal cell carcinoma. Hemispherx
Biopharma, Inc.

One Penn Center

TN= Ampligen 1617 JFK Boulevard

Philadelphia PA 19103

DD= 5/20/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Poly I: poly C12U Treatment of AIDS. Hemispherx Biopharma, Inc.

One Penn Center

TN= Ampligen 1617 JFK Boulevard

Philadelphia PA 19103

DD= 7/19/88 MA=

Poly I: poly C12U Treatment of chronic fatigue Hemispherx Biopharma,
Inc.

syndrome. One Penn Center

TN= Ampligen 1617 JFK Boulevard

Philadelphia PA 19103

DD= 12/9/93 MA=

Poly-ICLC Treatment of primary brain tumors. Salazar, Andres M. M.D. and

3202 Cleveland Avenue N.W.

TN= Washington DC 20008

DD= 3/17/97 MA=

Polyethylene Prophylaxis of hyperuricemia in Phoenix Pharmacologics,
Inc.

glycol-modified uricase cancer patients prone to develop 115 John Robert
Thomas Dr.

TN= Zurase tumor lysis syndrome during Exton PA 19341

chemotherapy.

DD= 9/14/99 MA=

Polyethylene Treatment of tumor lysis syndrome Phoenix Pharmacologics,
Inc.

glycol-modified uricase in cancer patients undergoing 115 John Robert
Thomas Dr.

TN= Zurase chemotherapy. Exton PA 19341

DD= 12/21/98 MA=

Polymeric oxygen Treatment of sickle cell anemia. Capmed USA

P.O. Box 14

TN= Bryn Mawr PA 19010

DD= 3/25/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Porcine fetal neural Treatment of Hoehn and Yahr stage 4 Diacrin, Inc.

dopaminergic cells and 5 Parkinson\'s disease. One Kendall Square

TN= NeuroCell-PD Cambridge MA 02139-1562

DD= 12/17/96 MA=

Porcine fetal neural Treatment of Hoehn and Yahr stage 4 Diacrin, Inc.

dopaminergic cells and 5 Parkinson\'s disease. One Kendall Square

TN= NeuroCell-PD Cambridge MA 02139-1562

DD= 12/17/96 MA=

Porcine fetal neural Treatment of Huntington\'s disease. Diacrin, Inc.

gabaergic cells and/or One Kendall Square

TN= NeuroCell-HD Cambridge MA 02129-1562

DD= 12/10/96 MA=

Porcine fetal neural Treatment of Huntington\'s disease. Diacrin, Inc.

gabaergic cells and/or One Kendall Square

TN= NeuroCell-HD Cambridge MA 02139-1562

DD= 12/10/96 MA=

Porcine Sertoli cells Treatment of Hoehn and Yahr stage Titan
Pharmaceuticals, Inc.

aseptically prepared for four and five Parkinson\'s disease. Post Office
Plaza

TN= N-Graft 50 Division Street, Suite 503

Somerville NJ 08876

DD= 6/24/97 MA=

Porfimer sodium For the photodynamic therapy of QLT Phototherapeutics,
Inc.

patients with primary or recurrent Lederle Laboratories

TN= Photofrin obstructing (either partially or 401 North Middletown Road

completely) esophageal carcinoma.

Pearl River NY 10965

DD= 6/6/89 MA= 12/27/95

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Porfimer sodium For the photodynamic therapy of QLT Phototherapeutics,
Inc.

patients with transitional cell Lederle Laboratories

TN= Photofrin carcinoma in situ of the urinary 401 North Middletown Road

bladder.

Pearl River NY 10965

DD= 11/15/89 MA=

Porfiromycin Treatment of cervical cancer. Boehringer Ingelheim

900 Ridgebury Road

TN= Promycin PO Box 368

Ridgefield CT 06877

DD= 3/13/97 MA=

Porfiromycin Treatment of head and neck cancer. Boehringer Ingelheim

900 Ridgebury Road

TN= Promycin PO Box 368

Ridgefield CT 06877

DD= 9/19/95 MA=

Potassium citrate Prevention of calcium renal stones University of Texas
Health

in patients with hypocitraturia. 5323 Harry Hines Blvd

TN= Urocit-K Dallas TX 75235

DD= 9/16/85 MA= 8/30/85

Potassium citrate Prevention of uric acid University of Texas Health

nephrolithiasis. 5323 Harry Hines Boulevard

TN= Urocit-K Dallas TX 75235

DD= 11/1/84 MA= 8/30/85

Potassium citrate For avoidance of the complication University of Texas
Health

of calcium stone formation in 5323 Harry Hines Blvd

TN= Urocit-K patients with uric lithiasis. Dallas TX 75235

DD= 5/29/84 MA= 8/30/85

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Potassium citrate and For the dissolution and control of Willen Drug
Company

citric acid uric acid and cysteine calculi in

TN= the urinary tract.

DD= 2/14/86 MA=

Pr-122 (redox-phenytoin) For the emergency rescue treatment Pharmos

of status epilepticus, grand mal 2 Innovation Drive

TN= type. Alachua FL 32615

DD= 7/5/90 MA=

PR-225 (redox-acyclovir) Treatment of herpes simplex Pharmos

encephalitis in individuals 2 Innovation Drive

TN= afflicted with AIDS. Alachua FL 32615

DD= 5/29/90 MA=

PR-239 (redox penicillin Treatment of AIDS associated Pharmos

G\) neurosyphilis. 2 Innovation Drive

TN= Alachua FL 32615

DD= 5/23/90 MA=

Pr-320 For the emergency rescue treatment Pharmos

(molecusol-carbamazepine of status epilepticus, grand mal 2 Innovation
Drive

TN= type. Alachua FL 32615

DD= 7/20/90 MA=

Pramiracetam Sulfate For the management of cognitive Cambridge
Neuroscience, Inc.

dysfunction and enhancement of 1 Kendall Square, Bldg. 700

TN= antidepressant activity associated Cambridge MA 02139

with electroconvulsive therapy.

DD= 11/4/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Praziquantel Treatment of neurocysticercosis. EM Pharmaceuticals, Inc.

TN=

DD= 4/18/88 MA=

Prednimustine Treatment of malignant Pharmacia Inc.

non-Hodgkin\'s lymphomas. P.O. Box 16529

TN= Sterecyt Columbus OH 43216-6529

DD= 6/17/85 MA=

Primaquine phosphate For use in combination with Sanofi Winthrop, Inc.

clindamycin hydrochloride in the 90 Park Avenue

TN= treatment of Pneumocystis carinii New York NY 10016

pneumonia associated with AIDS.

DD= 7/23/93 MA=

Progesterone Establishment and maintenance of Watson Laboratories, Inc.

pregnancy in women undergoing in 311 Bonnie Circle

TN= vitro fertilization or embryo Corona CA 91720

transfer procedures.

DD= 12/22/94 MA=

Propamidine isethionate Treatment of acanthamoeba Bausch & Lomb

0.1% ophthalmic solution keratitis. Pharmaceuticals Division

TN= Brolene 8500 Hidden River Parkway

Tampa FL 33637

DD= 3/10/88 MA=

Prostaglandin E1 enol Treatment of Fontaine Stage IV Alpha Therapeutic
Corp.

ester (AS-013) chronic critical limb ischemia. 5555 Valley Blvd.

TN= Los Angeles CA 90032

DD= 6/12/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Prostaglandin E1 in Treatment of ischemic ulceration of Alpha
Therapeutic Corporation

lipid emulsion the lower limbs due to peripheral 5555 Valley Boulevard

TN= Lipo-PGE1 arterial disease. Los Angeles CA 90032

DD= 9/10/96 MA=

Protein C concentrate For use in the prevention and Immuno Clinical
Research Corp.

treatment of purpura fulminans in 750 Lexington Avenue, 19th Floor

TN= Protein C meningococcemia. New York NY 10022

DD= 4/22/93 MA=

Protein C concentrate For replacement therapy in Baxter Healthcare
Corporation

congenital protein C deficiency for Hyland Division (Baxter Hyland)

TN= Protein C the prevention and treatment of 550 North Brand Blvd.

thrombosis, pulmonary emboli, and

purpura fulminans. Glendale CA 91203

DD= 6/23/92 MA=

Protein C concentrate For replacement therapy in patients Immuno
Clinical Research Corp.

with congenital or acquired 750 Lexington Avenue, 19th Floor

TN= Protein C protein C deficiency for the New York NY 10022

prevention and treatment of

warfarin-induced skin necrosis

during oral anticoagulation.

DD= 6/19/92 MA=

Protirelin Prevention of infant respiratory UCB Pharma, Inc.

distress syndrome associated with 1950 Lake Park Drive

TN= prematurity. Smyrna GA 30080

DD= 8/24/93 MA=

Protirelin injection Treatment of amyothrophic lateral Abbott
Laboratories

sclerosis.

TN=

DD= 1/10/85 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Pulmonary surfactant Prevention and treatment of infant Scios Nova, Inc.

replacement respiratory distress syndrome. 2450 Bayshore Parkway

TN= Mountain View CA 94043

DD= 12/5/88 MA=

Pulmonary surfactant For the treatment and prevention of Dey
Laboratories

replacement, porcine respiratory distress syndrome in 2751 Napa Valley
Corporate Drive

TN= Curosurf premature infants. Napa CA 94558

DD= 8/2/93 MA= 11/18/99

Purified extract of Treatment of immune DynaGen, Inc.

Pseudomonas aeruginosa thrombocytopenia purpura where it 99 Erie Street

TN= ImmuDyn is required to increase platelet Cambridge MA 02139

counts.

DD= 9/22/97 MA=

Purified type II Treatment of juvenile rheumatoid AutoImmune, Inc.

collagen arthritis. 128 Spring Street

TN= Colloral Lexington MA 02421

DD= 2/9/95 MA=

pVGI.1(VEGF2) Treatment of thromboangiitis Vascular Genetics, Inc.

obliterans. 200 Westpark Corporate Center

TN= 4364 South Alston Ave.

Durham NC 27713-2280

DD= 11/9/99 MA=

Quinacrine hydrochloride For prevention of recurrence of Lyphomed, Inc.

pneumothorax in patients at high

TN= risk of recurrence.

DD= 10/17/84 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Radiolabeled monoclonal Treatment of non-Hodgkin\'s Immunomedics, Inc.

antibody to CD22 antigen lymphoma. 300 American Rd.

TN= LymphoCIDE Morris Plains NJ 07950

DD= 7/13/98 MA=

Recombinant Treatment of severe meningococcal Xoma Corporation

bactericidal/permeabilit disease. 2910 Seventh Street

TN= Neuprex Berkeley CA 94710

DD= 6/22/98 MA=

Recombinant Treatment of short bowel syndrome. NPS Allelix Corp.

glycine2-human 6850 Goreway Dr.

TN= Mississauga, Ontario

L4V 1V7 Canada CA

DD= 6/29/00 MA=

Recombinant human acid Treatment of glycogen storage Genzyme Corporation

alpha-glucosidase disease type II. 15 Pleasant Street

TN= P.O. Box 9322

Framingham MA 01701-9322

DD= 8/19/97 MA=

Recombinant human Treatment of antithrombin III AT III LLC

antithrombin III dependent heparin resistance c/o Genzyme Corporation

TN= requiring anticoagulation. 15 Pleasant St. Connector, P.O.

Framingham MA 01701

DD= 4/6/00 MA=

Recombinant human Prophylactic treatment of Pharming N.V.

C1-esterase inhibitor angioedema caused by hereditary or Cipalstreet 3

TN= acquired C1-esterase inhibitor B-2440 Geel

deficiency.

Belgium BE

DD= 2/23/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Recombinant human Treatment of (acute attacks of) Pharming N.V.

C1-esterase inhibitor angioedema caused by hereditary or Cipalstreet 3

TN= acquired C1-esterase inhibitor B-2440 Geel

deficiency.

Belgium BE

DD= 2/23/99 MA=

Recombinant human CD4 Treatment of AIDS resulting from Genentech, Inc.

immunoglobulin G infection with HIV-1. 460 Point San Bruno Boulevard

TN= South San Francisco CA 94080

DD= 8/30/90 MA=

Recombinant human Clara Prevention of neonatal Claragen, Inc.

Cell 10kDa protein bronchopulmonary dysplasia in 335 Paint Branch Drive

TN= premature neonates with respiratory College Park MD 20742

distress syndrome.

DD= 7/13/98 MA=

Recombinant human Treatment of acute and chronic Biogen, Inc.

gelsolin respiratory symptoms of 14 Cambridge Center

TN= bronchiectasis. Cambridge MA 02142

DD= 3/6/95 MA=

Recombinant human Treatment of the respiratory Biogen, Inc.

gelsolin symptoms of cystic fibrosis. 14 Cambridge Center

TN= Cambridge MA 02124

DD= 1/12/94 MA=

Recombinant human highly For enzyme replacement therapy in Novazyme
Pharmaceuticals, Inc.

phosphorylated acid patients with all subtypes of 800 Research Parkway

TN= TBD glycogen storage disease type II Suite 200

(GSDII, Pompe Disease)

Oklahoma City OK 73104

DD= 9/20/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Recombinant human Treatment of growth hormone Pharmacia & Upjohn

insulin-like growth receptor deficiency. 7000 Portage Road

TN= IGF-1 Kalamazoo MI 49001-0199

DD= 6/7/95 MA=

Recombinant human Treatment of antibody-mediated Pharmacia & Upjohn

insulin-like growth growth hormone resistance in 7000 Portage Road

TN= IGF-1 patients with isolated growth Kalamazoo MI 49001-0199

hormone deficiency Ia.

DD= 6/7/95 MA=

Recombinant human Treatment of post-poliomyelitis Cephalon, Inc.

insulin-like growth syndrome. 145 Brandywine Parkway

TN= West Chester PA 19380-4245

DD= 10/13/95 MA=

Recombinant human Treatment of short-bowel syndrome GroPep Pty Ltd.

insulin-like growth as a result of resection of the Gate 11, Victoria
Dr.

TN= PV802 small bowel or as a result of Adelaide SA 5000

congenital dysfunction of the

intestines. Australia AU

DD= 2/16/00 MA=

Recombinant human Treatment of major burns that Celtrix Pharmaceuticals,
Inc.

insulin-like growth require hospitalization. 3055 Patrick Henry Dr.

TN= Santa Clara CA 95054

DD= 6/15/99 MA=

Recombinant human Treatment of renal cell carcinoma. Genetics Institute,
Inc.

interleukin-12 87 CambridgePark Drive

TN= Cambridge MA 02140

DD= 10/20/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Recombinant human Reducing the incidence and severity Amgen Inc.

keratinocyte growth of radiation-induced xerostomia. One Amgen Center
Dr.

TN= Thousand Oaks CA 91320-1799

DD= 12/20/99 MA=

Recombinant human For use in association with Serono Laboratories, Inc.

luteinizing hormone recombinant human follicle 100 Longwater Circle

TN= LHadi stimulating hormone for the Norwell MA 02061

treatment of women with chronic

anovulation due to hypogonadotropic

hypogonadism.

DD= 10/7/94 MA=

Recombinant human nerve Treatment of HIV-associated sensory Genentech,
Inc.

growth factor neuropathy. 1 DNA Way

TN= South San Francisco CA 94080

DD= 4/16/99 MA=

Recombinant human Treatment of progressive systemic Connetics
Corporation

relaxin sclerosis. 3400 West Bayshore Road

TN= Palo Alto CA 94303

DD= 11/3/95 MA=

Recombinant human Prevention of bronchopulmonary Bio-Technology General
Corp.

superoxide dismutase dysplasia in premature neonates 70 Wood Avenue,
South

TN= Oxsodrol weighing less than 1500 grams. Iselin NJ 08830

DD= 4/18/91 MA=

Recombinant human For use in accelerating platelet Genentech, Inc.

thrombopoietin recovery in patients undergoing 1 DNA Way

TN= hematopoietic stem cell South San Francisco CA

transplantation.

DD= 9/29/97 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Recombinant humanized Prevention of rejection of Biogen, Inc.

MAb 5c8 pancreatic islet cell transplants. 14 Cambridge Center

TN= Cambridge MA 02142

DD= 3/22/99 MA=

Recombinant humanized Prevention of rejection of solid Biogen, Inc.

MAb 5c8 organ transplants. 14 Cambridge Center

TN= Cambridge MA 02142

DD= 3/22/99 MA=

Recombinant humanized Prevention and treatment of Factor Biogen, Inc.

MAb 5c8 VIII/Factor IX inhibitors in 14 Cambridge Center

TN= patients with hemophilia A or B. Cambridge MA 02142

DD= 10/14/98 MA=

Recombinant humanized Treatment of immune Biogen, Inc.

monclonal antibody 5c8 thrombocytopenic purpura. 14 Cambridge Center

TN= Cambridge MA 02142

DD= 2/3/98 MA=

Recombinant humanized Treatment of systemic lupus Biogen, Inc.

monoclonal antibody 5c8 erythematosus. 14 Cambridge Center

TN= Cambridge MA 02142

DD= 2/18/98 MA=

Recombinant methionyl Treatment of amyotrophic lateral Amgen, Inc.

brain-derived sclerosis. One Amgen Center Dr.

TN= Thousand Oaks CA 91320-1799

DD= 11/28/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Recombinant methionyl Treatment of primary bone marrow Amgen, Inc.

human stem cell factor failure. One Amgen Center Drive

TN= Thousand Oaks CA 91320-1799

DD= 11/22/95 MA=

Recombinant retroviral For use as enzyme replacement Genetic Therapy,
Inc.

vector - therapy for patients with types I, 938 Clopper Road

TN= II, or III Gaucher disease. Gaithersburg MD 20878

DD= 11/15/93 MA=

Recombinant secretory Treatment of congenital alpha-1 Amgen Inc.

leucocyte protease antitrypsin deficiency. 3200 Walnut Street

TN= Boulder CO 80301

DD= 3/29/91 MA=

Recombinant secretory Treatment of cystic fibrosis. Amgen, Inc.

leucocyte protease 3200 Walnut Street

TN= Boulder CO 80301

DD= 3/29/91 MA=

Recombinant soluble Treatment of acquired Biogen, Inc.

human CD4 immunodeficiency syndrome. 14 Cambridge Center

TN= Receptin Cambridge MA 02142

DD= 11/20/89 MA=

Recombinant soluble Treatment of AIDS in patients Genentech, Inc.

human CD4 (rCD4) infected with HIV virus. 460 Point San Bruno Boulevard

TN= South San Francisco CA 94080

DD= 3/23/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Recombinant urate Prophylaxis of chemotherapy-induced Sanofi-Synthelabo
Research

oxidase hyperuricemia. 9 Great Valley Parkway

TN= Malvern PA 19355

DD= 10/11/00 MA=

Recombinant urate Treatment of malignancy-associated Sanofi-Synthelabo
Research

oxidase or chemotherapy-induced 9 Great Valley Parkway

TN= hyperuricemia. Malvern PA 19355

DD= 10/11/00 MA=

Recombinant vaccinia Treatment of cervical cancer. Cantab
Pharmaceuticals Research

(human papillomavirus) 310 Cambridge Science Park

TN= TA-HPV Cambridge CB4 OWG

Great Britain GB

DD= 8/24/94 MA=

Reduced L-glutathione Treatment of AIDS-associated Telluride
Pharmaceutical

cachexia. 146 Flanders Drive

TN= Cachexon Hillsborough NJ 08876

DD= 2/14/94 MA=

Remacemide Treatment of Huntington\'s disease. AstraZeneca LP

725 Chesterbrook Blvd.

TN= Ecovia Wayne PA 19087-5677

DD= 3/6/00 MA=

Respiratory syncytial Prophylaxis of respiratory MedImmune &
Massachussetts

virus immune globulin syncytial virus lower respiratory 35 West Watkins
Mill Road

TN= Respigam tract infections in infants and Gaithersburg MD 20878

young children at high risk of RSV

disease.

DD= 9/27/90 MA= 1/18/96

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Respiratory Syncytial Treatment of respiratory syncytial MedImmune, Inc.

Virus Immune Globulin virus lower respiratory tract 35 West Watkins Mill
Road

TN= Hypermune RSV infections in hospitalized infants Gaithersburg MD
20878

and young children.

DD= 9/27/90 MA=

Retroviral vector, R-GC Treatment of Gaucher disease. Genzyme
Corporation

and GC gene 1750 One Mountain Road

TN= P.O. Box 9322

Framingham MA 01701-9322

DD= 5/6/97 MA=

RGG0853, E1A lipid Treatment of ovarian cancer. Targeted Genetics
Corporation

complex 1100 Olive Way, Suite 100

TN= Seattle WA 98101

DD= 10/27/97 MA=

Rho (D) immune globulin Treatment of immune Rh Pharmaceuticals, Inc.

intravenous (human) thrombocytopenic purpura. 104 Chancellor Matheson
Road

TN= WinRho SD Winnipeg, Manitoba

Canada R3T 2N2 CA

DD= 11/9/93 MA= 3/24/95

Ribavirin Treatment of hemorrhagic fever with ICN Pharmaceuticals, Inc.

renal syndrome. ICN Plaza

TN= Virazole 3300 Hyland Avenue

Costa Mesa CA 92626

DD= 4/12/91 MA=

Ricin (blocked) For the ex-vivo purging of leukemic ImmunoGen, Inc.

conjugated murine mca cells from the bone marrow of 148 Sidney Street

TN= non-T cell acute lymphocytic Cambridge MA 02139

leukemia patients who are in

complete remission.

DD= 1/24/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ricin (blocked) Treatment of B-cell leukemia and ImmunoGen, Inc.

conjugated murine MCA B-cell lymphoma. 148 Sidney Street

TN= Cambridge MA 02139

DD= 11/17/88 MA=

Ricin (blocked) For use in the ex-vivo treatment of ImmunoGen, Inc.

conjugated murine MCA autologous bone marrow and 148 Sidney Street

TN= subsequent reinfusion in patients Cambridge MA 02139

with acute myelogenous leukemia.

DD= 2/1/90 MA=

Ricin (blocked) Treatment of myeloid leukemia, ImmunoGen, Inc.

conjugated murine MCA including AML, and blast crisis of 148 Sidney
Street

TN= CML. Cambridge MA 02139

DD= 8/3/89 MA=

Ricin (blocked) Treatment of small cell lung ImmunoGen, Inc.

conjugated murine MCA cancer. 148 Sidney Street

TN= Cambridge MA 02139

DD= 1/25/91 MA=

Ricin (blocked) Treatment of cutaneous T-cell ImmunoGen, Inc.

conjugated murine lymphomas, acute T-cell 148 Sidney Street

TN= leukemia-lymphoma, and related Cambridge MA 02139

mature T-cell malignancies.

DD= 9/6/94 MA=

Rifabutin Treatment of disseminated Pharmacia & Upjohn

Mycobacterium avium complex 7000 Portage Road

TN= disease. Unit 0633-298-113

Kalamazoo MI 49001-0199

DD= 12/18/89 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Rifabutin Prevention of disseminated Adria Laboratories, Inc.

Mycobacterium avium complex disease P.O. Box 16529

TN= Mycobutin in patients with advanced HIV Columbus OH 43216

infection.

DD= 12/18/89 MA= 12/23/92

Rifalazil Treatment of pulmonary PathoGenesis Corporation

tuberculosis. 201 Elliott Avenue West

TN= Suite 150

Seattle WA 98119

DD= 4/13/99 MA=

Rifampin For antituberculosis treatment Hoechst Marion Roussel

where use of the oral form of the P.O. Box 9627

TN= Rifadin I.V. drug is not feasible. Kansas City MO 64134

DD= 12/9/85 MA= 5/25/89

Rifampin, isoniazid, For the short-course treatment of Hoechst Marion
Roussel

pyrazinamide tuberculosis. P.O. Box 9627

TN= Rifater Kansas City MO 64134

DD= 9/12/85 MA= 5/31/94

Rifapentine Treatment of Mycobacterium avium Hoechst Marion Roussel ,
Inc.

complex in patients with AIDS. P.O. Box 9627

TN= Priftin Mail Station: H3-M2516

Kansas City MO 64134-0627

DD= 6/9/95 MA=

Rifapentine Prophylactic treatment of Hoechst Marion Roussel, Inc.

Mycobacterium avium complex in P.O. Box 9627

TN= Priftin patients with AIDS and a CD4+ count Mail Station: H3-M2516

less than or equal to 75/mm3.

Kansas City MO 64134-0627

DD= 3/12/96 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Rifapentine Treatment of pulmonary Hoechst Marion Roussel

tuberculosis. P.O. Box 9627

TN= Priftin Mail Station: H3-M2516

Kansas City MO 64134-0627

DD= 6/9/95 MA= 6/22/98

Rifaximin Treatment of hepatic Salix Pharmaceuticals, Inc.

encephalopathy. 3600 W. Bayshore Road, Suite 205

TN= Normix Palo Alto CA 94303

DD= 2/10/98 MA=

RII retinamide Treatment of myelodysplastic Sparta Pharmaceuticals, Inc.

syndromes. 111 Rock Road

TN= Horsham PA 19044-2310

DD= 5/6/93 MA=

Riluzole Treatment of Huntington\'s disease. Rhone-Poulenc Rorer

500 Arcola Road

TN= Rilutek PO Box 5096

Collegeville PA 19426-0800

DD= 10/15/96 MA=

Riluzole Treatment of amyotrophic lateral Rhone-Poulenc Rorer

sclerosis. 500 Arcola Road, P.O. Box 1200

TN= Rilutek Collegeville PA 19426

DD= 3/16/93 MA= 12/12/95

Rituximab Treatment of non-Hodgkin\'s B-cell IDEC Pharmaceuticals
Corporation

lymphoma. 3030 Callan Road

TN= Rituxan San Diego CA 92121

DD= 6/13/94 MA= 11/26/97

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Roquinimex To prolong time to relapse in Pharmacia & Upjohn

leukemia patients who have 7000 Portage Road

TN= Linomide undergone autologous bone marrow Kalamazoo MI 49001-0199

transplantation.

DD= 7/1/93 MA=

rSP-C lung surfactant Treatment of adult respiratory Byk Gulden
Pharmaceuticals

distress syndrome. Byk-Gulden StraBe 2

TN= Venticute 78467 Konstanz

Germany DE

DD= 4/3/00 MA=

S-adenosylmethionine Treatment of AIDS-myelopathy. Di Rocco, Alessandro
M.D.

Beth Israel Medical Center,

TN= Philips Building, Suite 2Q; 10

New York NY 10003

DD= 4/30/98 MA=

Sacrosidase Treatment of congenital Orphan Medical, Inc.

sucrase-isomaltase deficiency. 13911 Ridgedale Drive

TN= Sucraid Suite 475

Minnetonka MN 55305

DD= 12/10/93 MA= 4/9/98

Sargramostim To reduce neutropenia and Immunex Corporation

leukopenia and decrease the 51 University Street

TN= Leukine incidence of death due to infection Seattle WA 98101

in patients with acute myelogenous

leukemia.

DD= 3/6/95 MA= 9/15/95

Sargramostim Treatment of neutropenia associated Immunex Corporation

with bone marrow transplant, for 51 University Street

TN= Leukine the treatment of graft failure and Seattle WA 98101

delay of engraftment, and for the

promotion of early engraftment.

DD= 5/3/90 MA= 3/5/91

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Satumomab pendetide Detection of ovarian carcinoma. Cytogen Corporation

600 College Road East

TN= Oncoscint CR/OV Princeton NJ 08540

DD= 9/25/89 MA= 12/29/92

SB-408075 For pancreatic cancer SmithKline Beecham

1250 S. Collegeville Road

TN= Collegeville PA 19426-0989

DD= 12/7/00 MA=

SCH 58500 Treatment of primary ovarian Schering Corporation

cancer. 2000 Galloping Hill Rd.

TN= Kenilworth NJ 07033

DD= 4/12/99 MA=

Secalciferol Treatment of familial Teva Pharmaceuticals USA

hypophosphatemic rickets. 650 Cathill Rd.

TN= Osteo-D Sellersville PA 18960

DD= 7/26/93 MA=

Secretory leukocyte Treatment of bronchopulmonary Synergen, Inc.

protease inhibitor dysplasia. 1885 33rd Street

TN= Boulder CO 80301

DD= 6/30/92 MA=

Selegiline HCl As an adjuvant to levodopa and Somerset Pharmaceuticals,
Inc.

carbidopa treatment of idiopathic 777 South Harbor Island

TN= Eldepryl Parkinson\'s disease (paralysis Tampa FL 33602

agitans), postencephalitic

Parkinsonism, and symptomatic

Parkinsonism.

DD= 11/7/84 MA= 6/5/89

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Sermorelin acetate Adjunct to gonadotropin therapy in Serono
Laboratories, Inc.

the induction of ovulation in women 100 Longwater Circle

TN= Geref with anovulatory or Norwell MA 02061

oligo-ovulatory infertility who

fail to ovulate in response to

adequate treatment with clomiphene

DD= 2/13/90 MA=

Sermorelin acetate Treatment of idiopathic or organic Serono
Laboratories, Inc.

growth hormone deficiency in 100 Longwater Circle

TN= Geref children with growth failure. Norwell MA 02061

DD= 9/14/88 MA= 9/26/97

Sermorelin acetate Treatment of AIDS-associated Serono Laboratories,
Inc.

catabolism/weight loss. 100 Longwater Circle

TN= Geref Norwell MA 02061

DD= 12/5/91 MA=

Serratia marcescens Treatment of primary brain Cell Technology, Inc.

extract (polyribosomes) malignancies. 1668 Valtec Lane

TN= Imuvert Boulder CO 80306

DD= 9/7/88 MA=

Short chain fatty acid Treatment of chronic radiation Richard I. Breuer,
M.D.

enema proctitis. 1000 Central Street, Suite 615

TN= Colomed Evanston IL 60201

DD= 8/19/97 MA=

Short chain fatty acid Treatment of the active phase of Richard I.
Breuer

solution ulcerative colitis with involvement 1000 Central Street, Suite
615

TN= Colomed restricted to the left side of the Evanston IL 60201

colon.

DD= 5/29/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Silver sulfadiazine and Prevention of mortality in severely Synthes
(USA)

cerium nitrate burned patients. 1690 Russell Road

TN= Flammacerium PO Box 1766

Paoli PA 19301

DD= 11/17/99 MA=

SK&F 110679 For the long term treatment of SmithKline Beecham

children who have growth failure One Franklin Plaza

TN= due to a lack of adequate Philadelphia PA 19101

endogenous growth hormone

secretion.

DD= 5/23/90 MA=

Sodium Treatment of secondary amyloidosis. Neurochem, Inc.

1,3-propanedisulfonate 7220 Frederick Banting, Suite

TN= Saint-Laurent, Quebec

Canada H4S 2A1 CA

DD= 4/6/99 MA=

Sodium dichloroacetate Treatment of severe head injury. Questcor
Pharmaceuticals, Inc.

26118 Research Road

TN= Ceresine Hayward CA 94545

DD= 6/14/99 MA=

Sodium dichloroacetate Treatment of homozygous familial Stacpoole, Peter
W. M.D., Ph.D.

hypercholesterolemia. University of Florida

TN= P.O. Box 100277

Gainesville FL 32610

DD= 6/11/90 MA=

Sodium dichloroacetate Treatment of congenital lactic Stacpoole, Peter
W. M.D., Ph.D.

acidosis. University of Florida

TN= P.O. Box 100277

Gainesville FL 32610

DD= 6/11/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Sodium dichloroacetate Treatment of lactic acidosis in Stacpoole, Peter
W. M.D., Ph.D.

patients with severe malaria. University Of Florida

TN= P.O. Box 100277

Gainesville FL 32610

DD= 11/10/94 MA=

Sodium dichloroacetate Treatment of congenital lactic Questcor
Pharmaceuticals, Inc.

acidosis. 26118 Research Road

TN= Hayward CA 94545

DD= 12/31/97 MA=

Sodium For use in conjunction with a Theragenics Corporation

monomercaptoundecahydro- thermal or epithermal neutron beam

TN= in boron nuclear capture therapy of

glioblastoma multiforme.

DD= 12/18/84 MA=

Sodium For use in boron neutron capture Neutron Technology Corp.&

Monomercaptoundecahydro- therapy (BNCT) in the treatment of 877 Main
Street, Suite 402

TN= Borocell glioblastoma multiforme. Boise ID 83702

DD= 4/15/92 MA=

Sodium phenylbutyrate For use as an adjuct to surgery, Elan
Pharmaceutical Research

radiation therapy and chemotherapy 1300 Gould Dr.

TN= for the treatment of patients with Gainesville GA 30504

primary or recurrent malignant

glioma.

DD= 4/24/98 MA=

sodium phenylbutyrate Treatment of urea cycle disorders: Medicis
Pharmaceutical Corp.

carbamylphosphate synthetase 8125 N. Hayden Road

TN= Buphenyl deficiency, ornithine Scottsdale AZ 85258

transcarbamylase deficiency, and

arginiosuccinic acid synthetase

deficiency.

DD= 11/22/93 MA= 7/29/94

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

sodium phenylbutyrate Treatment for sickling disorders, Medicis
Pharmaceutical Corp.

which include S-S hemoglobinopathy, 8125 N. Hayden Road

TN= S-C hemoglobinopathy, and Scottsdale AZ 85258

S-thalassemia hemoglobinopathy.

DD= 7/2/92 MA=

Sodium tetradecyl Treatment of bleeding esophageal Elkins-Sinn, Inc.

sulfate varices. 2 Esterbrook Lane

TN= Sotradecol Cherry Hill NJ 08003

DD= 6/10/86 MA=

Soluble complement Prevention of post-cardiopulmonary Avant
Immunotherapeutics, Inc.

receptor type 1 bypass syndrome in children 119 Fourth Ave.

TN= undergoing cardiopulmonary bypass. Needham MA 02494-2725

DD= 3/6/00 MA=

Soluble recombinant Prevention or reduction of adult T Cell Sciences,
Inc.

human complement respiratory distress syndrome. 119 Fourth Avenue

TN= Needham Heights MA 02194

DD= 11/21/94 MA=

Somatostatin Adjunct to the non-operative Ferring Laboratories, Inc.

management of secreting cutaneous 400 Rella Boulevard, Suite 201

TN= Zecnil fistulas of the stomach, duodenum, Suffern NY 10901

small intestine (jejunum and

ileum), or pancreas.

DD= 6/20/88 MA=

Somatostatin Treatment of bleeding esophageal UCB Pharmaceuticals, Inc.

varices. 1950 Lake Park Drive

TN= Smyrna GA 30080

DD= 12/22/94 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Somatrem for injection For long-term treatment of children Genentech,
Inc.

who have growth failure due to a 460 Point San Bruno Boulevard

TN= Protropin lack of adequate endogenous growth South San Francisco CA
94080

hormone secretion.

DD= 12/9/85 MA= 10/17/85

Somatrem for injection Treatment of short stature Genentech, Inc.

associated with Turner\'s syndrome. 460 Point San Bruno Boulevard

TN= Protropin South San Francisco CA 94080

DD= 12/9/85 MA=

Somatropin Treatment of short stature Eli Lilly and Company

associated with Turner syndrome. Lilly Corporate Center

TN= Humatrope Indianapolis IN 46285

DD= 5/8/90 MA= 3/11/97

Somatropin Treatment of short stature Novo Nordisk Pharmaceuticals

associated with Turner\'s syndrome. 100 Overlook Center

TN= Norditropin Suite 200

Princeton NJ 08540

DD= 11/5/87 MA=

Somatropin Adjunct for the induction of Novo Nordisk Pharmaceuticals

ovulation in women with infertility 100 Overlook Center

TN= Norditropin due to hypogonadotropic Suite 200

hypogonadism or bilateral tubal

occlusion or unexplained Princeton NJ 08540

infertility, who are undergoing in

DD= 9/1/87 MA=

Somatropin Treatment of cachexia associated Bio-Technology General Corp.

with AIDS. 70 Wood Avenue, South

TN= Biotropin Iselin NJ 08830

DD= 2/12/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Somatropin For use in the long-term treatment Genentech, Inc.

of children who have growth failure 460 Point San Bruno Boulevard

TN= Nutropin due to a lack of adequate South San Francisco CA 94080

endogenous growth hormone

secretion.

DD= 3/6/87 MA= 10/17/85

Somatropin Treatment of adults with growth Pharmacia & Upjohn

hormone deficiency. 7000 Portage Road

TN= Genotropin Kalamazoo MI 49001-0199

DD= 9/6/94 MA= 10/31/97

Somatropin (rDNA) For the enhancement of nitrogen Serono Laboratories,
Inc.

retention in hospitalized patients 100 Longwater Circle

TN= Saizen suffering from severe burns. Norwell MA 02061

DD= 5/3/89 MA=

Somatropin (r-DNA) For use alone or in combination Serono Laboratories,
Inc.

with glutamine in the treatment of 100 Longwater Circle

TN= Serostim short bowel syndrome. Norwell MA 02061

DD= 3/6/95 MA=

Somatropin (r-DNA) for Treatment of children with Serono Laboratories,
Inc.

injection AIDS-associated failure-to-thrive 100 Longwater Circle

TN= Serostim including AIDS-associated wasting. Norwell MA 02061

DD= 3/26/96 MA=

Somatropin (rDNA origin) Treatment of idiopathic or organic Serono
Laboratories, Inc.

growth hormone deficiency in 100 Longwater Circle

TN= Saizen children with growth failure. Norwell MA 02061

DD= 3/6/87 MA= 10/8/96

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Somatropin (rDNA origin) Long-term treatment of children who Genentech,
Inc.

have growth failure due to a lack 1 DNA Way

TN= Nutropin Depot of adequate endogenous growth South San Francisco CA

hormone secretion.

DD= 10/28/99 MA= 12/22/99

Somatropin (rDNA origin) Treatment of growth failure in Novo Nordisk
Pharmaceuticals

injection children due to inadequate growth 100 Overlook Center

TN= Norditropin hormone secretion. Suite 200

Princeton NJ 08540

DD= 7/10/87 MA= 6/20/00

somatropin \[rDNA\] Treatment of growth failure in Pharmacia and Upjohn
Company

children who were born small for 7000 Portage Road

TN= Genotropin gestational age. Kalamazoo MI 49001

DD= 12/27/00 MA=

Somatropin \[rDNA\] Treatment of short stature in Pharmacia & Upjohn

patients with Prader-Willi 7000 Portage Rd.

TN= Genotropin syndrome. 0633-298-113

Kalamazoo MI 49001-0199

DD= 7/6/99 MA= 6/20/00

Somatropin for injection Treatment of short stature Genentech, Inc.

associated with Turner\'s syndrome. 460 Point San Bruno Boulevard

TN= Nutropin South San Francisco CA 94080

DD= 3/23/89 MA= 12/30/96

Somatropin for injection Treatment of AIDS-associated Serono
Laboratories, Inc.

catabolism/weight loss. 100 Longwater Circle

TN= Serostim Norwell MA 02061

DD= 11/15/91 MA= 8/23/96

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Somatropin for injection As replacement therapy for growth Genentech,
Inc.

hormone deficiency in adults after 460 Point San Bruno Boulevard

TN= Nutropin epiphyseal closure. South San Francisco CA 94080

DD= 11/18/96 MA= 12/15/97

Somatropin for injection For the long-term treatment of Eli Lilly and
Company

children who have growth failure Lilly Corporate Center

TN= Humatrope due to inadequate secretion of Indianapolis IN 46285

normal endogenous growth hormone.

DD= 6/12/86 MA= 3/8/87

Somatropin for injection Treatment of growth retardation Genentech, Inc.

associated with chronic renal 460 Point San Bruno Boulevard

TN= Nutropin failure. South San Francisco CA 94080

DD= 8/4/89 MA= 11/17/93

Sorivudine Treatment of herpes zoster Bristol-Myers Squibb

(shingles) in immunocompromised 5 Research Parkway

TN= BRAVAVIR patients. P.O. Box 5100

Wallingford CT 06492

DD= 11/9/95 MA=

Sotalol HCl Prevention of life threatening Berlex Laboratories, Inc.

ventricular tachyarrhythmias. 300 Fairfield Road

TN= Betapace Wayne NJ 07470

DD= 9/23/88 MA=

Sotalol HCl Treatment of life-threatening Berlex Laboratories, Inc.

ventricular tachyarrhythmias. 300 Fairfield Road

TN= Betapace Wayne NJ 07470

DD= 9/23/88 MA= 10/30/92

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Spiramycin For symptomatic relief and Rhone-Poulenc Rorer

parasitic cure of chronic 500 Arcola Road

TN= Rovamycine cryptosporidiosis in patients with Collegeville PA 19426

immunodeficiency.

DD= 10/17/84 MA=

ST1-RTA immunotoxin (SR Treatment of patients with Sanofi Winthrop, Inc.

44163\) B-chronic lymphocytic leukemia. 9 Great Valley Parkway

TN= Malvern PA 19355

DD= 8/12/87 MA=

ST1-RTA immunotoxin (SR Prevention of acute graft versus Sanofi
Winthrop, Inc.

44163\) host disease in allogenic bone 9 Great Valley Parkway

TN= marrow transplantation. Malvern PA 19355

DD= 8/12/87 MA=

Sterile talc Treatment of malignant pleural Novatech SA

effusion. Avenue du Vent des Dames - Z.l.

TN= Steritalc 13685 Aubagne

France

DD= 12/8/97 MA=

Sterile talc Treatment of pneumothorax. Novatech SA

Avenue du Vent des Dames - Z.l.

TN= Steritalc 13685 Aubagne

France

DD= 12/8/97 MA=

Sterile talc powder Treatment of malignant pleural Bryan Corporation

effusion. 4 Plympton Street

TN= Sclerosol Woburn MA 01801

DD= 9/18/95 MA= 12/24/97

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

SU101 Treatment of malignant glioma. Sugen, Inc.

230 East Grand Ave.

TN= South San Francisco CA

DD= 5/25/95 MA=

SU101 Treatment of ovarian cancer. Sugen, Inc.

230 East Grand Ave.

TN= South San Francisco CA

DD= 3/12/96 MA=

Succimer Prevention of cystine kidney stone Sanofi Winthrop, Inc.

formation in patients with 90 Park Avenue

TN= Chemet homozygous cystinuria who are prone New York NY 10016-1389

to stone development.

DD= 11/5/90 MA=

Succimer Treatment of lead poisoning in Bock Pharmacal Company

children. P.O. Box 419056

TN= Chemet capsules Saint Louis MO 63141-9056

DD= 5/9/84 MA= 12/22/88

Succimer Treatment of mercury intoxication. Sanofi Winthrop, Inc.

90 Park Avenue

TN= Chemet New York NY 10016-1389

DD= 3/22/91 MA=

Sucralfate Treatment of oral mucositis and Fuisz Technologies, Ltd.

stomatitis following radiation 14555 Avion at Lakeside

TN= therapy for head and neck cancer. Chantilly VA 20151

DD= 7/15/93 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Sucralfate suspension Treatment of oral ulcerations and Darby
Pharmaceuticals, Inc.

dysphagia in patients with 100 Banks Avenue

TN= epidermolysis bullosa. Rockville Centre NY 11570

DD= 3/4/91 MA=

Sucralfate suspension Treatment of oral complications of Darby
Pharmaceuticals, Inc.

chemotherapy in bone marrow 100 Banks Avenue

TN= transplant patients. Rockville Centre NY 11570

DD= 3/12/90 MA=

Sulfadiazine For use in combination with Eon Labs Manufacturing, Inc.

pyrimethamine for the treatment of 227-15 North Conduit Avenue

TN= Toxoplasma gondii Laurelton NY 11413

encephalitis in patients with and

without AIDS.

DD= 3/14/94 MA= 7/29/94

Sulfapyridine Treatment of dermatitis Jacobus Pharmaceutical Company

herpetiformis. 37 Cleveland Lane

TN= P.O. Box 5290

Princeton NJ 08540

DD= 9/10/90 MA=

Superoxide dismutase For protection of donor organ Pharmacia-Chiron
Partnership

(human) tissue from damage or injury 4560 Horton Street

TN= mediated by oxygen-derived free Emeryville CA 94608

radicals that are generated during

the necessary periods of ischemia

(hypoxia, anoxia), and especially

DD= 3/6/85 MA=

Superoxide dismutase Prevention of reperfusion injury to Bio-Technology
General Corp.

(recombinant human) donor organ tissue. 70 Wood Avenue, South

TN= Oxsodrol Iselin NJ 08830

DD= 5/17/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Suramin Treatment of hormone-refractory Warner-Lambert Company

prostate cancer. Parke-Davis Pharmaceutical

TN= Metaret 2800 Plymouth Road

Ann Arbor MI 48105-2430

DD= 5/6/97 MA=

Surface active extract Treatment and prevention of ONY, Inc.

of saline lavage of respiratory failure due to 1576 Sweet Home Road

TN= Infasurf pulmonary surfactant deficiency in Amherst NY 14228

preterm infants.

DD= 6/7/85 MA= 7/1/98

Surfactant (human) Prevention and treatment of Merritt, T. Allen M.D.

(amniotic fluid derived) neonatal respiratory distress 2516 Stockton
Boulevard

TN= Human Surf syndrome. Sacramento CA 95817

DD= 3/25/87 MA=

Synsorb Pk Treatment of verocytotoxogenic E. Synsorb Biotech Inc.

coli infections. 201, 1204 Kensington Road, N.W.

TN= Calgary, Alberta

Canada T2N 3P5 CA

DD= 7/17/95 MA=

Synthetic Human Treatment of hypoparathyroidism Orphan Pharmaceuticals,
U.S.,

Parathyroid Hormone 1-34 1101 Kermit Drive,

TN= Suite 608

Nashville TN 37217

DD= 1/26/01 MA=

Synthetic human secretin For use in obtaining desquamated ChiRhoClin,
Inc.

pancreatic cells for cytopathologic 15500 Gallaudet Ave.

TN= examination in pancreatic Silver Spring MD 20905-4176

carcinoma.

DD= 6/16/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Synthetic human secretin For use in conjunction with ChiRhoClin, Inc.

diagnostic procedures for 15500 Gallaudet Ave.

TN= pancreatic disorders to increase Silver Spring MD 20905-4176

pancreatic fluid secretion.

DD= 3/7/00 MA=

Synthetic human secretin For use in the evaluation of ChiRhoClin, Inc.

exocrine pancreas function. 1550 Gallaudet Ave.

TN= Silver Spring MD 20905-4176

DD= 6/16/99 MA=

Synthetic human secretin For use in the diagnosis of ChiRhoClin, Inc.

gastrinoma associated with 15500 Gallaudet Ave.

TN= Zollinger-Ellison syndrome. Silver Spring MD 20905-4176

DD= 6/16/99 MA=

Synthetic porcine For use in the evaluation of ChiRhoClin, Inc.

secretin exocrine pancreas function. 15500 Gallaudet Ave.

TN= Silver Spring MD 20905-4176

DD= 6/18/99 MA=

Synthetic porcine For use in obtaining desquamated ChiRhoClin, Inc.

secretin pancreatic cells for cytopathologic 15500 Gallaudet Ave.

TN= examination in pancreatic Silver Spring MD 20905-4176

carcinoma.

DD= 6/18/99 MA=

Synthetic porcine For use in the diagnosis of ChiRhoClin, Inc.

secretin gastrinoma associated with 15500 Gallaudet Ave.

TN= Zollinger-Ellison syndrome. Silver Spring MD 20905-4176

DD= 6/18/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Synthetic porcine For use in conjunction with ChiRhoClin, Inc.

secretin diagnostic procedures for 15500 Gallaudet Ave.

TN= pancreatic disorders to increase Silver Spring MD 20905-4176

pancreatic fluid secretion.

DD= 3/7/00 MA=

T4 endonuclease V, To prevent cutaneous neoplasms and AGI Dermatics

liposome encapsulated other skin abnormalities in 205 Buffalo Avenue

TN= xeroderma pigmentosum. Freeport NY 11520

DD= 6/27/89 MA=

Tacrolimus Prophylaxis of Fujisawa USA, Inc.

graft-versus-host-disease. 3 Parkway North Center

TN= Prograf Deerfield IL 60015

DD= 4/6/98 MA=

TAK-603 Treatment of Crohn\'s disease. Tap Holdings Inc.

2355 Waukegan Road

TN= Deerfield IL 60015

DD= 5/13/98 MA=

Technetium Tc 99m For the identification of ovarian Endocyte, Inc.

pterotetramide carcinomas. 1205 Kent Ave.

TN= Lafayette IN 47906

DD= 2/16/00 MA=

Technetium Tc99m For use in detecting, by imaging, NeoRx Corporation

anti-melanoma murine metastases of malignant melanoma. 410 West Harrison

TN= Oncotrac Melanoma Seattle WA 98119-4007

DD= 6/2/87 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Technetium Tc99m murine Diagnostic imaging in the Immunomedics, Inc.

monoclonal antibody evaluation of the extent of disease 300 American
Road

TN= LymphoScan in patients with histologically Morris Plains NJ 07950

confirmed diagnosis of

non-Hodgkin\'s B-cell lymphoma,

acute B-cell lymphoblastic leukemia

DD= 4/7/92 MA=

Technetium Tc99m murine Detection of hCG producing tumors Immunomedics,
Inc.

monoclonal antibody to such as germ cell and trophoblastic 300 American
Road

TN= Immuraid, hCG-Tc-99m cell tumors. Morris Plains NJ 07950

DD= 8/7/89 MA=

Technetium Tc99m murine Detection of alpha-fetoprotein Immunomedics,
Inc.

monoclonal antibody to producing germ cell tumors. 300 American Road

TN= AFP-Scan Morris Plains NJ 07950

DD= 8/1/89 MA=

Technetium Tc99m murine Detection of hepatocellular Immunomedics, Inc.

monoclonal antibody to carcinoma and hepatoblastoma. 300 American Road

TN= Immuraid, AFP-Scan Morris Plains NJ 07950

DD= 8/1/89 MA=

Technetium Tc99m Diagnosis or assessment of Theseus Imaging Corporation

rh-Annexin V rejection status in heart, 124 Mount Auburn Street

TN= Apomate heart-lung, single lung, or Suite 200 North

bilateral lung transplants.

Cambridge MA 02138

DD= 11/3/00 MA=

Temoporfin Palliative treatment of recurrent, Scotia Pharmaceuticals
Ltd.

refractory or second primary Scotia House, Castle Business

TN= Foscan squamous cell carcinomas of the Stirling

head and neck in patients

considered to be incurable with Scotland FK9 4TZ GB

surgery or radiotherapy.

DD= 10/28/99 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Temozolomide Treatment of recurrent malignant Schering-Plough Research

glioma. 2000 Galloping Hill Rd.

TN= Temodar Kenilworth NJ 07033

DD= 10/5/98 MA= 8/11/99

Temozolomide Treatment of advanced metastatic Schering-Plough Research

melanoma. 2000 Galloping Hill Rd.

TN= Temodal Kenilworth NJ 07033

DD= 10/14/98 MA=

Teniposide Treatment of refractory childhood Bristol-Myers Squibb

acute lymphocytic leukemia. 5 Research Parkway

TN= Vumon for injection P.O. Box 5100

Wallingford CT 06492

DD= 11/1/84 MA= 7/14/92

Teriparatide Treatment of idiopathic Henri Beaufour Institute USA,

osteoporosis. 27 Maple St.

TN= Parathar Milford MA 01757

DD= 10/28/99 MA=

Teriparatide Diagnostic agent to assist in Rhone-Poulenc Rorer

establishing the diagnosis in 500 Arcola Road

TN= Parathar patients presenting with clinical Collegeville PA 19426

and laboratory evidence of

hypocalcemia due to either

hypoparathyroidism or

DD= 1/9/87 MA= 12/23/87

Terlipressin Treatment of bleeding esophageal Ferring Laboratories, Inc.

varices. 400 Rella Boulevard, Suite 201

TN= Glypressin Suffern NY 10901

DD= 3/6/86 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Testosterone Treatment of weight loss in AIDS Unimed Pharmaceuticals,
Inc.

patients with HIV-associated Four Parkway North

TN= Androgel wasting. fDeerfield IL 60015-2544

DD= 2/5/96 MA=

Testosterone For use as physiologic testosterone Watson Laboratories

replacement in androgen deficient Research Park

TN= TheraDerm HIV+ patients with an associated 417 Wakara Way

weight loss.

Salt Lake City UT 84108

DD= 9/22/97 MA=

Testosterone propionate Treatment of vulvar dystrophies. Star
Pharmaceuticals, Inc.

ointment 2% 1990 N.W. 44th Street

TN= Pompano Beach FL 33064

DD= 7/31/91 MA=

Testosterone sublingual Treatment of constitutional delay Bio-Technology
General Corp.

of growth and puberty in boys. 70 Wood Avenue South

TN= Iselin NJ 08830

DD= 1/16/91 MA=

Tetrabenazine Treatment of Huntington\'s disease. Lifehealth Limited

Doltie House Kingfisher Way

TN= Wallsend Tyne & Wear

NE28 9NX UK

DD= 12/11/97 MA=

Tetrabenazine Treatment of moderate/severe Lifehealth Limited

tardive dyskinesia. Doltic house Kinfisher Way

TN= Wallsend Tyne & Wear

NE28 9NX UK

DD= 5/12/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Tetraiodothyroacetic Suppression of thyroid stimulating Danforth, Jr.,
MD, Elliot

acid hormone in patients with University of Vermont

TN= well-differentiated cancer of the 84 Beartown Rd.

thyroid gland.

Underhill VT 05489

DD= 5/1/00 MA=

Thalidomide Treatment of HIV-associated wasting Celgene Corporation

syndrome. P.O. Box 4914

TN= Synovir 7 Powder Horn Drive

Warren NJ 07059

DD= 3/11/96 MA=

Thalidomide Treatment and maintenance of Pediatric Pharmaceuticals, Inc.

reactional lepromatous leprosy. 718 Bradford Avenue

TN= Westfield NJ 07090

DD= 11/15/88 MA=

Thalidomide Prevention of graft versus host Andrulis Research
Corporation

disease. 11800 Baltimore Avenue, Suite

TN= Beltsville MD 20705

DD= 3/5/90 MA=

Thalidomide Treatment of erythema nodosum Celgene Corporation

leprosum. P.O. Box 4914

TN= Thalomid 7 Powder Horn Drive

Warren NJ 07059

DD= 7/26/95 MA= 7/16/98

Thalidomide Treatment of graft versus host Andrulis Research Corporation

disease. 11800 Baltimore Avenue, Suite

TN= Beltsville MD 20705

DD= 3/5/90 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Thalidomide Treatment of primary brain Celgene Corporation

malignancies. 7 Powder Horn Dr.

TN= Warren NJ 07059

DD= 2/27/98 MA=

Thalidomide Treatment and prevention of Andrulis Research Corporation

recurrent aphthous ulcers in 11800 Baltimore Avenue, Suite

TN= severely, terminally Beltsville MD 20705

immunocompromised patients.

DD= 5/15/95 MA=

Thalidomide Treatment of Crohn\'s disease. Celgene Corporation

7 Powder Horn Dr.

TN= Thalomid Warren NJ 07059

DD= 4/6/99 MA=

Thalidomide Treatment of graft versus host Pediatric Pharmaceuticals,
Inc.

disease in patients receiving bone 718 Bradford Avenue

TN= marrow transplantation. Westfield NJ 07090

DD= 9/19/88 MA=

Thalidomide Treatment of severe recurrent Celgene Corporation

aphthous stomatitis in severely, P.O. Box 4914

TN= terminally immunocompromised 7 Powder Horn Srive

patients.

Warren NJ 07059

DD= 5/1/95 MA=

Thalidomide Treatment of multiple myeloma. Celgene Corporation

7 Powder Horn Dr.

TN= Thalomid Warren NJ 07059

DD= 10/14/98 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Thalidomide Prevention of graft versus host Pediatric Pharmaceuticals,
Inc.

disease in patients receiving bone 718 Bradford Avenue

TN= marrow transplantation. Westfield NJ 07090

DD= 9/19/88 MA=

Thalidomide Treatment of the clinical Celgene Corporation

manifestations of mycobacterial P.O. Box 4914

TN= infection caused by Mycobacterium 7 Powder Horn Drive

tuberculosis and non-tuberculous

mycobacteria. Warren NJ 07059

DD= 1/12/93 MA=

Thalidomide Treatment of Kaposi\'s sarcoma. Celgene Corporation

7 Powder Horn Dr.

TN= Warren NJ 07059

DD= 7/29/98 MA=

Thymalfasin Treatment of DiGeorge anomaly with SciClone Pharmaceuticals,
Inc.

immune defects. 901 Mariner\'s Island Blvd.

TN= Zadaxin San Mateo CA 94404-1593

DD= 1/8/98 MA=

Thymalfasin Treatment of chronic active SciClone Pharmaceuticals, Inc.

hepatitis B. 901 Mariner\'s Island Blvd.

TN= Zadaxin San Mateo CA 94404-1593

DD= 5/3/91 MA=

Thymalfasin Treatment of hepatocellular SciClone Pharmaceuticals, Inc.

carcinoma. 901 Mariner\'s Blvd., Suite 205

TN= Zadaxin San Mateo CA 94404

DD= 3/6/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Thymoxamine HCl Reversal of phenylephrine-induced Iolab Pharmaceuticals

mydriasis in patients who have 500 Iolab Drive

TN= narrow anterior angles and are at Claremont CA 91711

risk of developing an acute attack

of angle-closure glaucoma following

mydriasis.

DD= 11/16/87 MA=

Thyrotropin alpha As an adjunct in the diagnosis of Genzyme Corporation

thyroid cancer. One Kendall Square

TN= Thyrogen Cambridge MA 02139

DD= 2/24/92 MA= 11/30/98

Tiapride Treatment of Tourette\'s syndrome. Sanofi-Synthelabo, Inc.

9 Great Valley Parkway

TN= PO Box 3026

Malvern PA 19355

DD= 4/21/98 MA=

Tiazofurin Chronic myelogenous leukemia (CML) ICN Pharmaceuticals, Inc.
(ICN)

(2-Beta-D-ribofuranosyl- 3300 Hyland Avenue

TN= Costa Mesa CA 92626

DD= 12/27/00 MA=

Tiopronin Prevention of cystine Pak, Charles Y.C. M.D.

nephrolithiasis in patients with The University of Texas Health

TN= Thiola homozygous cystinuria. 5323 Harry Hines Boulevard

Dallas TX 75235

DD= 1/17/86 MA= 8/11/88

Tiratricol For use in combination with Laphal Laboratoires

levo-thyroxine to suppress thyroid 48 Bis, Rue des Belles-Feuilles

TN= Triacana stimulating hormone in patients 75116 Paris

with well-differentiated thyroid

cancer who are intolerant to France FR

adequate doses of levo-thyroxine

DD= 8/13/91 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Tizanidine HCl Treatment of spasticity associated Athena Neurosciences,
Inc.

with multiple sclerosis and spinal 800 Gateway Boulevard

TN= Zanaflex cord injury. South San Francisco CA 94080

DD= 1/31/94 MA=

Tobramycin Treatment of bronchiectasis PathoGenesis Corporation

patients infected with Pseudomonas 201 Elliott Avenue West

TN= Tobi aeruginosa. Suite 150

Seattle WA 98119

DD= 6/18/99 MA=

Tobramycin for Treatment of bronchopulmonary Pathogenesis Corporation

inhalation infections of Pseudomonas 201 Elliott Avenue West, Suite

TN= TOBI aeruginosa in cystic fibrosis Seattle WA 98119

patients.

DD= 10/13/94 MA= 12/22/97

Tocophersolan oral Treatment of vitamin E deficiency Sterling Winthrop

solution (vitamin resulting from malabsorption due to 9 Great Valley
Parkway

TN= prolonged cholestatic Malvern PA 19355

hepatobiliary disease.

DD= 4/15/88 MA=

Topiramate Treatment of Lennox-Gastaut R. W. Johnson Pharmaceutical

syndrome. Route 202, P.O. Box 300

TN= Topamax Raritan NJ 08869-0602

DD= 11/25/92 MA=

Toremifene Hormonal therapy of metastatic Orion Corporation

carcinoma of the breast. P.O. Box 65

TN= Fareston 02101 ESPOO

Finland

DD= 9/19/91 MA= 5/29/97

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Toremifene Treatment of desmoid tumors. Orion Corporation

P.O. Box 65

TN= 02101 Espoo

Finland

DD= 8/17/93 MA=

Tositumomab and iodine I Treatment of non-Hodgkin\'s B-cell Coulter
Pharmaceutical, Inc.

131 tositumomab lymphoma. 550 California Avenue

TN= Bexxar Suite 200

Palo Alto CA 94306

DD= 5/16/94 MA=

Tranexamic acid Treatment of patients with Pharmacia Inc.

congenital coagulopathies who are P.O. Box 16529

TN= Cyklokapron undergoing surgical procedures Columbus OH 43216

(e.g. dental extractions).

DD= 10/29/85 MA= 12/30/86

Tranexamic acid Treatment of patients undergoing Pharmacia Inc.

prostatectomy where there is P.O. Box 16529

TN= Cyklokapron hemorrhage or risk of hemorrhage as Columbus OH 43216

a result of increased fibrinolysis

or fibrinogenolysis.

DD= 7/23/87 MA=

Tranexamic acid Treatment of hereditary Pharmacia Inc.

angioneurotic edema. P.O. Box 16529

TN= Cyklokapron Columbus OH 43216

DD= 9/9/85 MA=

Transforming growth Treatment of full thickness macular Celtrix
Pharmaceuticals, Inc.

factor-beta 2 holes. 3055 Patrick Henry Drive

TN= Santa Clara CA 95054

DD= 12/18/92 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Transgenic human alpha 1 Treatment of cystic fibrosis. PPL Therapeutics
(Scotland)

antitrypsin Roslin, Edinburgh

TN= EH25 9PP Scotland GB

DD= 3/6/98 MA=

Transgenic human alpha 1 Treatment of emphysema secondary to PPL
Therapeutics (Scotland)

antitrypsin alpha 1 antitrypsin deficiency. Roslin, Edinburgh

TN= EH25 9PP Scotland GB

DD= 5/19/99 MA=

Trastuzumab Treatment of patients with Genentech, Inc.

pancreatic cancer that overexpress 1 DNA Way

TN= Herceptin p185HER2. South San Francisco CA

DD= 12/14/99 MA=

Treosulfan Treatment of ovarian cancer. Medac GmbH

Fehlandtstrasse 3

TN= Ovastat D-20354 Hamburg

Germany DE

DD= 5/16/94 MA=

Tretinoin Treatment of acute and chronic Aronex Pharmaceuticals, Inc.

leukemia. 8707 Technology Forest Place

TN= Atragen The Woodlands TX 77381-1191

DD= 1/14/93 MA=

Tretinoin Treatment of acute promyelocytic Hoffmann-La Roche, Inc.

leukemia. 340 Kingsland Street

TN= Vesanoid Nutley NJ 07110

DD= 10/24/90 MA= 11/22/95

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Tretinoin Treatment of squamous metaplasia of Hannan Ophthalmic
Marketing

the ocular surface epithelia 34 Sherrill Rd.

TN= (conjunctiva and/or cornea) with Marshfield MA 02050

mucous deficiency and

keratinization.

DD= 4/15/85 MA=

Trientine HCl Treatment of patients with Wilson\'s Merck Sharp & Dohme
Research

disease who are intolerant, or Division Of Merck And Company

TN= Syprine inadequately responsive to West Point PA 19486

penicillamine.

DD= 12/24/84 MA= 11/8/85

Trimetrexate Treatment of metastatic osteogenic Medimmune Oncology, Inc.

sarcoma. One Tower Bridge

TN= Neutrexin 100 Front St., Suite 400

West Conshohocken PA 19428

DD= 8/10/00 MA=

Trimetrexate glucuronate Treatment of pancreatic Medimmune Oncology,
Inc.

adenocarcinoma. One Tower Bridge

TN= 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 7/25/85 MA=

Trimetrexate glucuronate Treatment of metastatic carcinoma Medimmune
Oncology, Inc.

of the head and neck (i.e. buccal One Tower Bridge

TN= cavity, pharynx, and larynx). 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 7/25/85 MA=

Trimetrexate glucuronate Treatment of patients with advanced Medimmune
Oncology, Inc.

non-small cell carcinoma of the One Tower Bridge

TN= lung. 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 1/13/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Trimetrexate glucuronate Treatment of Pneumocystis carinii Medimmune
Oncology, Inc.

pneumonia in AIDS patients. One Tower Bridge

TN= Neutrexin 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 5/15/86 MA= 12/17/93

Trimetrexate glucuronate Treatment of metastatic colorectal Medimmune
Oncology, Inc.

adenocarcinoma. One Tower Bridge

TN= 100 Front Street, Suite 400

West Conshohocken PA 19428

DD= 7/25/85 MA=

Triptorelin pamoate For use in the palliative treatment Debio R.A. Inc.

of advanced ovarian carcinoma of 7929 Westpark Drive, Suite 400

TN= Decapeptyl Injection epithelial origin. Mclean VA 22102

DD= 8/10/90 MA=

Trisaccharides A and B Treatment of moderate to very Chembiomed, Ltd.

severe clinical forms of P.O. Box 8050, Edmonton,

TN= transfusion reactions arising from Alberta CA

ABO incompatible transfusions of

blood, blood products, and blood

derivatives.

DD= 8/3/87 MA=

Trisaccharides A and B Treatment of moderate to severe Chembiomed, Ltd.

clinical forms of hemolytic disease P.O. Box 8050, Station F

TN= Biosynject of the newborn arising from Edmonton, Alberta

placental transfer of antibodies

against blood group substances A Canada T6H 4NP CA

and B.

DD= 4/12/87 MA=

Trisaccharides A and B Prevention of ABO medical hemolytic Chembiomed,
Ltd.

reactions arising from P.O. Box 8050, Station F

TN= Biosynject ABO-incompatible bone marrow Edmonton, Alberta

transplantation.

Canada T6H 4NP CA

DD= 4/15/88 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Trisaccharides A and B For use in ABO-incompatible solid Chembiomed,
Ltd.

organ transplantation, including P.O. Box 8050, Station F

TN= Biosynject kidney, heart, liver and pancreas. Edmonton, Alberta

Canada T6H 4NP CA

DD= 4/20/87 MA=

Trisodium citrate For use in leukapheresis Hemotec Medical Products,
Inc.

concentration procedures. Box 19255

TN= Hemocitrate Johnston RI 02919

DD= 6/15/95 MA=

Troleandomycin Treatment of severe Szefler, Stanley M. M.D.

steroid-requiring asthma. National Jewish Center for

TN= 1400 Jackson Street

Denver CO 80206

DD= 9/21/89 MA=

Tumor necrosis Treatment of symptomatic patients Serono Laboratories,
Inc.

factor-binding protein 1 with AIDS including all patients 100 Longwater
Circle

TN= with CD4 counts less than 200 cells Norwell MA 02061

per mm3.

DD= 1/6/93 MA=

Tumor necrosis Treatment of symptomatic patients Serono Laboratories,
Inc.

factor-binding protein with the AIDS including all 100 Longwater Circle

TN= patients with CD4 T-cell counts Norwell MA 02061

less than 200 cells per mm3.

DD= 1/6/93 MA=

Tyloxapol Treatment of cystic fibrosis. Kennedy & Hoidal, M.D.\'s

University of Utah Health

TN= Supervent 50 North Medical Drive, Room

Salt Lake City UT 84132-0001

DD= 3/8/95 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ubiquinone Treatment of mitochondrial Gel-Tec, Division of Tishcon

cytopathies. 30 New York Ave.

TN= Ubiqgel PO Box 331

Westbury NY 11590

DD= 12/14/99 MA=

Uridine 5\'-triphosphate Treatment of cystic fibrosis. Inspire
Pharmaceuticals, Inc.

4222 Emperor Boulevard, Suite

TN= Durham NC 27703

DD= 12/4/95 MA=

Uridine 5\'-triphosphate To facilitate the removal of lung Inspire
Pharmaceuticals, Inc.

secretions in the treatment of 4222 Emperor Boulevard, Suite

TN= patients with primary ciliary Durham NC 27703

dyskinesia.

DD= 6/26/96 MA=

Urofollitropin For the initiation and Serono Laboratories, Inc.

re-initiation of spermatogenesis in 100 Longwater Circle

TN= Fertinex adult males with reproductive Norwell MA 02061

failure due to hypothalamic or

pituitary dysfunction,

hypogonadotropic hypogonadism.

DD= 12/5/97 MA=

Urofollitropin For induction of ovulation in Serono Laboratories, Inc.

patients with polycystic ovarian 100 Longwater Circle

TN= Metrodin disease who have an elevated LH/FSH Norwell MA 02061

ratio and who have failed to

respond to adequate clomiphene

citrate therapy.

DD= 11/25/87 MA= 9/18/86

Urogastrone For acceleration of corneal Chiron Vision

epithelial regeneration and healing 500 Iolab Drive

TN= of stromal incisions from corneal Claremont CA 91711

transplant surgery.

DD= 11/1/84 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Ursodiol Management of the clinical signs Novartis Pharmaceuticals

and symptoms associated with 59 Route 10

TN= Actigall primary biliary cirrhosis. East Hanover NJ 07936-1080

DD= 2/19/91 MA=

Ursodiol Treatment of patients with primary Axcan Pharma Inc.

biliary cirrhosis. 597 Laurier Blvd

TN= URSO Mount St. Hilaire Quebec H7L

Canada CA

DD= 6/20/91 MA= 12/10/97

Valine, isoleucine and Treatment of hyperphenylalaninemia. Leas Research
Products

leucine 78 Fallon Drive

TN= VIL North Haven CT 06473

DD= 1/5/96 MA=

Valrubicin Treatment of carcinoma in situ of Anthra Pharmaceuticals,
Inc.

the urinary bladder. 103 Carnegie Center, Suite 102

TN= Valstar Princeton NJ 08540

DD= 5/23/94 MA= 9/25/98

Vapreotide Prevention of early postoperative Debiopharm S.A.

complications following pancreatic 17 rue des Terreaux

TN= Octastatin resection. CH-1000 Lausanne 9

Switzerland CH

DD= 3/6/00 MA=

Vapreotide Treatment of esophageal variceal Debiopharm S.A.

hemorrhage patients with portal 17 rue des Terreaux

TN= Octastatin hypertension. CH-1000 Lausanne 9

Switzerland CH

DD= 1/10/00 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Vapreotide Treatment of gastrointestinal and Debiopharm S.A.

pancreatic fistulas. 17 rue des Terreaux

TN= Octastatin CH-1000 Lausanne 9

Switzerland CH

DD= 1/10/00 MA=

Vasoactive intestinal Treatment of acute esophageal food Research
Triangle

polypeptide impaction. 200 Westpark Corporate Center

TN= 4364 South Alston Avenue

Durham NC 27713-2280

DD= 6/23/93 MA=

vigabatrin Treatment of infantile spasms. Aventis Pharmaceuticals Inc.

P.O. Box 9627

TN= Sabril Kansas City MO 64137

DD= 6/12/00 MA=

Viloxazine HCl Treatment of cataplexy. Stuart Pharmaceuticals

Division of ICI Americas

TN= Catatrol Wilmington DE 19897

DD= 6/11/84 MA=

Viloxazine HCl Treatment of narcolepsy. Stuart Pharmaceuticals

Division of ICI Americas

TN= Catatrol Wilmington DE 19897

DD= 6/11/84 MA=

Virulizin Treatment of pancreatic cancer. Lorus Therapeutics Inc.

7100 Woodbine Avenue, Suite 215

TN= Virulizin Markham, ON L3R 5J2

Canada

DD= 2/1/01 MA=

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Xenogeneic hepatocytes Treatment of severe liver failure. Circe
Biomedical, Inc.

99 Hayden Ave.

TN= HepatAssist Liver Lexington MA 02421-7995

DD= 11/27/98 MA=

Yttrium-90 radiolabeled Treatment of ovarian carcinoma. Immunomedics,
Inc.

humanized monoclonal 300 American Rd.

TN= Cea-Cide Morris Plains NJ 07950

DD= 8/3/99 MA=

Zalcitabine Treatment of AIDS. Hoffmann-La Roche, Inc.

340 Kingsland Street

TN= Hivid Nutley NJ 07110

DD= 6/28/88 MA= 6/19/92

Zalcitabine Treatment of AIDS. National Cancer Institute, DCT

NIH, Executive Plaza North, Room

TN= Bethesda MD 20892

DD= 12/9/86 MA=

Zidovudine Treatment of AIDS related complex. Glaxo Wellcome Inc.

5 Moore Drive

TN= Retrovir Research Triangle Park NC 27709

DD= 5/12/87 MA= 3/19/87

Zidovudine Treatment of AIDS. Glaxo Wellcome Inc.

5 Moore Drive

TN= Retrovir Research Triangle Park NC 27709

DD= 7/17/85 MA= 3/19/87

Name: Sponsor & Address

Generic Name DD=Date Designated

TN=Trade Name Indication Designated: MA=Marketing Approval

Zinc acetate Treatment of Wilson\'s disease. Lemmon Company

1510 Delp Drive

TN= Galzin Kulpsville PA 19443

DD= 11/6/85 MA= 1/28/97

Zoledronate Treatment of tumor induced Novartis Pharmaceuticals Corp.

hypercalcemia. 59 Route 10

TN= Zometa, Zabel East Hanover NJ 07936-1080

DD= 8/18/00 MA=