Federal Register / Vol. 74, No. 113 / Monday, June 15, 2009 / Notices 28255 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0254] 

Determination That THORAZINE 

(Chlorpromazine Hydrochloride) 

Injection and 18 Other Drug Products 

Were Not Withdrawn From Sale for 

Reasons of Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that the 19 drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. This determination means 

that FDA will not begin procedures to 

withdraw approval of abbreviated new 

drug applications (ANDAs) that refer to 

these drug products, and it will allow 

FDA to continue to approve ANDAs that 

refer to the products as long as they 

meet relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Olivia Pritzlaff, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6308, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Public Law 98– 

417) (the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

sponsors must, with certain exceptions, 

show that the drug for which they are 

seeking approval contains the same 

active ingredient in the same strength 

and dosage form as the ‘‘listed drug,’’ 

which is a version of the drug that was 

previously approved. Sponsors of 

ANDAs do not have to repeat the 

extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (the act) 

(21 U.S.C. 355(j)(7)), which requires 

FDA to publish a list of all approved 

drugs. FDA publishes this list as part of 

the ‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is generally known as the 

‘‘Orange Book.’’ Under FDA regulations, 

a drug is withdrawn from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness, or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a) (21 CFR 

314.161(a)), the agency must determine 

whether a listed drug was withdrawn 

from sale for reasons of safety or 

effectiveness: (1) Before an ANDA that 

refers to that listed drug may be 

approved; (2) whenever a listed drug is 

voluntarily withdrawn from sale and 

ANDAs that refer to the listed drug have 

been approved; and (3) when a person 

petitions for such a determination under 

21 CFR 10.25(a) and 10.30. Section 

314.161(d) provides that if FDA 

determines that a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness, the agency will 

initiate proceedings that could result in 

the withdrawal of approval of the 

ANDAs that refer to the listed drug. 

FDA has become aware that the drug 

products listed in the table in this 

document are no longer being marketed. 

(As requested by the applicants, FDA 

withdrew approval of NDA 20–225 for 

IMDUR (isosorbide mononitrate) 

Extended-Release Tablets in the Federal 

Register of February 11, 2009 (74 FR 

6896) and NDA 11–556 for ANTURANE 

(sulfinpyrazone) Tablets and Capsules, 

NDA 15–500 for TOLINASE 

(tolazamide) Tablets, NDA 18–285 for 

VISKEN (pindolol) Tablets, NDA 20– 

137 for DEMADEX (torsemide) 

Injection, and NDA 20–154 for VIDEX 

(didanosine) Chewable Tablets in the 

Federal Register of May 19, 2009 (74 FR 

23407)). 

Application No. Drug Applicant 

NDA 9–149 THORAZINE (chlorpromazine hydrochloride 

(HCI)) Injection, 25 milligrams (mg)/milliliter 

(mL) 

GlaxoSmithKline, 2301 Renaissance Blvd., 

King of Prussia, PA 19406 

NDA 9–149 THORAZINE (chlorpromazine HCl) Oral Concentrate, 30 mg/mL and 100 mg/mL Do. 

NDA 9–149 THORAZINE (chlorpromazine HCl) Oral 

Syrup, 10 mg/5 mL 

Do. 

NDA 9–149 THORAZINE (chlorpromazine) Suppositories, 

25 mg and 100 mg 

Do. 

NDA 11–552 STELAZINE (trifluoperazine HCl) Tablets, 

Equivalent to (EQ) 1 mg base, EQ 2 mg 

base, EQ 5 mg base, and EQ 10 mg base 

Do. 

NDA 11–556 ANTURANE (sulfinpyrazone) Tablet, 100 mg Novartis Pharmaceuticals Corp., One Health 

Plaza, East Hanover, NJ 07963 

NDA 11–556 ANTURANE (sulfinpyrazone) Capsule, 200 

mg 

Do. 

NDA 12–940 ISORDIL (isosorbide dinitrate) Sublingual 

Tablets, 2.5 mg, 5 mg, and 10 mg 

Biovail Pharmaceuticals, Inc., 700 Route 

202–206 North, Bridgewater, NJ 08807– 

0980 

NDA 15–500 TOLINASE (tolazamide) Tablets, 100 mg, 

250 mg, and 500 mg 

Pfifzer, Inc., 235 East 42d St., New York, NY 

10017 


pwalker on PROD1PC71 with NOTICES
28256 Federal Register / Vol. 74, No. 113 / Monday, June 15, 2009 / Notices 

Application No. Drug Applicant 

NDA 18–154 LONITEN (minoxidil) Tablets, 2.5 mg and 10 

mg 

Pharmacia & Upjohn Co., c/o Pfizer, Inc. 

NDA 18–285 VISKEN (pindolol) Tablets, 5 mg and 10 mg Novartis Pharmaceuticals Corp. 

NDA 18–445 DOLOBID (diflunisal) Tablets, 250 mg and 

500 mg 

Merck & Co., Inc., Sunneytown Pike, P.O. 

Box 4, BLA–20, West Point, PA 19486 

NDA 19–661 CYTOVENE IV (ganciclovir sodium) Injection, 

EQ 500 mg base/vial 

Roche Laboratories, Inc., 340 Kingsland St., 

Nutley, NJ 07110–1199 

NDA 20–027 CARDIZEM (diltiazem HCl) Injection, 5 mg/ 

mL and 25 mg/vial 

Biovail Pharmaecuticals, Inc. 

NDA 20–137 DEMADEX (torsemide) Injection, 20 mg/2 mL 

(10 mg/mL) and 50 mg/5 mL (10 mg/mL) 

Roche Laboratories, Inc. 

NDA 20–154 VIDEX (didanosine) Chewable Tablets, 25 

mg, 50 mg, 100 mg, 150 mg, and 200 mg 

Bristol-Myers Squibb Co., P.O. Box 5100, 

Wallingford, CT 06492–7660 

NDA 20–225 IMDUR (isosorbide mononitrate) ExtendedRelease Tablets, 30 mg, 60 mg, and 120 

mg 

Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033 

NDA 21–238 KYTRIL (granisetron HCl) Oral Solution, EQ 

2 mg base/10 mL 

Roche Laboratories, Inc. 

NDA 21–301 LEVOXYL (levothyroxine sodium) Tablet, 0.3 

mg 

King Pharmaceuticals, Inc., 501 Fifth St., 

Bristol, TN 37620 

FDA has reviewed its records and, 

under § 314.161, has determined that 

the drug products listed in this 

document were not withdrawn from 

sale for reasons of safety or 

effectiveness. Accordingly, the agency 

will continue to list the drug products 

listed in this document in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. The 

‘‘Discontinued Drug Product List’’ 

identifies, among other items, drug 

products that have been discontinued 

from marketing for reasons other than 

safety or effectiveness. 

Approved ANDAs that refer to the 

NDAs listed in this document are 

unaffected by the discontinued 

marketing of the products subject to 

those NDAs. Additional ANDAs that 

refer to these products may also be 

approved by the agency if they comply 

with relevant legal and regulatory 

requirements. If FDA determines that 

labeling for these drug products should 

be revised to meet current standards, the 

agency will advise ANDA applicants to 

submit such labeling. 

Dated: June 5, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–14000 Filed 6–12–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. in accordance with 

35 U.S.C. 207 to achieve expeditious 

commercialization of results of 

Federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. 

ADDRESSES: Licensing information and 

copies of the U.S. patent applications 

listed below may be obtained by writing 

to the indicated licensing contact at the 

Office of Technology Transfer, National 

Institutes of Health, 6011 Executive 

Boulevard, Suite 325, Rockville, 

Maryland 20852–3804; telephone: 301/ 

496–7057; fax: 301/402–0220. A signed 

Confidential Disclosure Agreement will 

be required to receive copies of the 

patent applications. 

Improved Antibodies Against ErbB4/ 

Her4 

Description of Technology: ErbB4/ 

Her4 is a receptor tyrosine kinase that 

regulates cell proliferation, cell 

differentiation and cell survival. ErbB4 

has been implicated in the pathology of 

numerous cancers (e.g., breast cancer, 

non-small cell lung carcinoma, 

adenocarcinoma), as well as psychiatric 

disorders (e.g., schizophrenia). As a 

result, ErbB4 is an excellent target for 

developing therapies against these 

diseases. Unfortunately, the study of 

ErbB4 has been slowed by the lack of 

highly specific and functional 

antibodies against the receptor. 

In order to overcome the deficiencies 

with current ErbB4 antibodies, NIH 

inventors have generated three rabbit 

monoclonal antibodies with improved 

properties and versatility. Specifically, 

the mAb-6, mAb-7 and mAb-10 

hybridomas produce antibodies with a 

high degree of specificity and affinity 

for ErbB4. These antibodies recognize 

specific epitopes on the intracellular 

domains of ErbB4 without crossreaction against other proteins, and can 

be used successfully in the 

immunostaining of fixed tissue. Each 

antibody recognizes both human and 

mouse ErbB4, whereas only mAb-7 and 

mAb-10 recognize rat ErbB4. 

Applications: 

• Basic research tool for the study of 

ErbB4; 


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