Document ID: FDA-2012-N-0190-0001
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of 35 New Drug Applications and 64 Abbreviated New Drug Applications: Abbott Laboratories et al.
Posted Date: 2012-03-19T04:00Z

[Federal Register Volume 77, Number 53 (Monday, March 19, 2012)]
[Notices]
[Pages 16039-16042]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-6591]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0190]

Abbott Laboratories et al.; Withdrawal of Approval of 35 New Drug 
Applications and 64 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 35 new drug applications (NDAs) and 64 abbreviated new drug 
applications (ANDAs) from multiple applicants. The holders of the 
applications notified the Agency in writing that the drug products were 
no longer marketed and requested that the approval of the applications 
be withdrawn.

DATES: Effective Date: April 18, 2012.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications listed in 
table 1 in this document have informed

[[Page 16040]]

FDA that these drug products are no longer marketed and have requested 
that FDA withdraw approval of the applications under the process in 
Sec.  314.150(c) (21 CFR 314.150(c)). The applicants have also, by 
their requests, waived their opportunity for a hearing. Withdrawal of 
approval of an application or abbreviated application under Sec.  
314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
NDA 005545..................  Dicumarol Tablets...  Abbott Laboratories,
                                                     PA77/Bldg. AP30-1E,
                                                     200 Abbott Park
                                                     Rd., Abbott Park,
                                                     IL 60064-6157.
NDA 005845..................  Benadryl              McNeil Consumer
                               (diphenhydramine      Healthcare,
                               hydrochloride         Division of McNeil-
                               (HCl)), Benadryl      PPC, Inc., 7050
                               with Ephedrine        Camp Hill Rd., Fort
                               Sulfate, and          Washington, PA
                               Caladryl              19034-2299.
                               (diphenhydramine
                               HCl and calamine).
NDA 006146..................  Benadryl              Do.
                               (diphenhydramine
                               HCl)) Injection.
NDA 006773..................  Artane                Lederle
                               (trihexyphenidyl      Laboratories, d/b/a
                               HCl) Tablets and      Wyeth
                               Capsules and Artane   Pharmaceuticals,
                               (trihexyphenidyl)     P.O. Box 8299,
                               Elixir.               Philadelphia, PA
                                                     19101-8299.
NDA 009486..................  Benadryl              McNeil Consumer
                               (diphenhydramine      Healthcare.
                               HCl)) Injection
                               Preservative Free.
NDA 010021..................  Placidyl              Abbott Laboratories,
                               (ethchlorvynol)       200 Abbott Park
                               Capsules.             Rd., Abbott Park,
                                                     IL 60064.
NDA 011552..................  Stelazine             GlaxoSmithKline,
                               (trifluoperazine      P.O. Box 13398,
                               HCl).                 Five Moore Dr.,
                                                     Research Triangle
                                                     Park, NC 27709-
                                                     3398.
NDA 012524..................  Enduron               Abbott Laboratories,
                               (methyclothiazide)    PA77/Bldg. AP30-1E,
                               Tablets, 2.5          200 Abbott Park
                               milligrams (mg) and   Rd., Abbott Park,
                               5 mg.                 IL 60064-6157.
NDA 012775..................  Enduronyl and         Do.
                               Enduronyl Forte
                               (methyclothiazide
                               and deserpidine)
                               Tablets.
NDA 014684..................  Aventyl               Eli Lilly and Co.,
                               (nortriptyline HCl)   Lilly Corp. Center,
                               Capsules.             Indianapolis, IN
                                                     46285.
NDA 017577..................  Ditropan (oxybutynin  Janssen
                               chloride) Tablets.    Pharmaceuticals
                                                     Inc., c/o Johnson &
                                                     Johnson
                                                     Pharmaceutical
                                                     Research and
                                                     Development, LLC,
                                                     920 Route 202, P.O.
                                                     Box 300, Raritan,
                                                     NJ 08869.
NDA 018473..................  Ventolin (albuterol)  GlaxoSmithKline.
                               Inhalation
                               Aerosol\1\.
NDA 018557..................  Fansidar              Hoffman-La Roche,
                               (sulfadoxine and      Inc., 340 Kingsland
                               pyrimethamine)        St., Nutley, NJ
                               Tablets, 500 mg and   07110-1199.
                               25 mg.
NDA 018709..................  Capozide (captopril   Bristol-Myers Squibb
                               and                   Co., P.O. Box 4000,
                               hydrochlorothiazide   Princeton, NJ 08543-
                               ) Tablets.            4000.
NDA 018814..................  Heparin Sodium in 5%  Baxter Healthcare
                               Dextrose Injection.   Corp., 1620
                                                     Waukegan Rd., MPGR-
                                                     AL, McGaw Park, IL
                                                     60085.
NDA 019297..................  Novantrone            EMD Serono, One
                               (mitoxantrone HCl)    Technology Place,
                               Injection.            Rockland, MA 02370.
NDA 019508..................  Axid (nizatidine)     SmithKline Beecham
                               Capsules.             Corp., d/b/a
                                                     GlaxoSmithKline,
                                                     P.O. Box 13398,
                                                     Five Moore Dr.,
                                                     Research Triangle
                                                     Park, NC 27709-
                                                     3398.
NDA 019915..................  Monopril (fosinopril  Bristol-Myers Squibb
                               sodium) Tablets, 10   Co.
                               mg, 20 mg, and 40
                               mg.
NDA 019946..................  Nuromax (doxacurium   Abbott Laboratories,
                               chloride) Injection   P76/Bldg. AP30-1E,
                               1 mg/milliliter       Abbott Park, IL
                               (mL).                 60064-6157.
NDA 019960..................  Manoplax              Do.
                               (flosequinan)
                               Tablets.
NDA 020057..................  Ceredase              Genzyme Corp., 500
                               (alglucerase)         Kendall St.,
                               Injection.            Cambridge, MA
                                                     02142.
NDA 020088..................  Norplant System       Wyeth
                               (levonorgestrel)      Pharmaceuticals,
                               Implants.             Inc., P.O. Box
                                                     8299, Philadelphia,
                                                     PA 19101-8299.
NDA 020101..................  Prozac (fluoxetine    Eli Lilly and Co.
                               HCl) Oral Solution,
                               20 mg/5 mL.
NDA 020236..................  Serevent (salmeterol  GlaxoSmithKline.
                               xinafoate)
                               Inhalation
                               Aerosol\1\.
NDA 020286..................  Monopril-HCT          Bristol-Myers Squibb
                               (fosinopril sodium    Co.
                               and
                               hydrochlorothiazide
                               ) Tablets, 20 mg/
                               12.5 mg and 10 mg/
                               12.5 mg.
NDA 020403..................  Zofran (ondansetron   Glaxo Wellcome
                               HCl) Injection.       Manufacturing Pte
                                                     Limited, d/b/a
                                                     GlaxoSmithKline,
                                                     1250 Collegeville
                                                     Rd., UP4110,
                                                     Collegeville, PA
                                                     19426.
NDA 020627..................  Norplant II System    Wyeth
                               (levonorgestrel)      Pharmaceuticals,
                               Implants.             Inc.
NDA 020828..................  Fortovase             Hoffman-La Roche,
                               (saquinavir)          Inc.
                               Capsules, 200 mg.
NDA 020860..................  Levlite (ethinyl      Bayer HealthCare
                               estradiol and         Pharmaceuticals
                               levonorgestrel)       Inc., P.O. Box
                               Tablets.              1000, Montville, NJ
                                                     07045.
NDA 020984..................  Raplon (rapacuronium  Organon USA Inc.,
                               bromide) for          2000 Galloping Hill
                               Injection.            Rd., Kenilworth, NJ
                                                     07033.
NDA 021120..................  Novantrone            EMD Serono.
                               (mitoxantrone HCl)
                               Injection.
NDA 021793..................  Reglan ODT            Meda Pharmaceuticals
                               (metoclopramide)      Inc., 200 North
                               Tablets.              Cobb Parkway, Suite
                                                     428, Marietta, GA
                                                     30062.
ANDA 040207.................  Prochlorperazine      Duramed
                               Maleate Tablets       Pharmaceuticals,
                               USP, 5 mg and 10 mg.  Inc., 400 Chestnut
                                                     Rd., Woodcliff
                                                     Lake, NJ 07677.
ANDA 040231.................  Chlorpromazine HCl    Pharmaceutical
                               Oral Concentrate      Associates, Inc.,
                               USP, 30 mg/mL.        201 Delaware St.,
                                                     Greenville, SC
                                                     29605.
NDA 050526..................  Staticin              Bristol-Myers Squibb
                               (erythromycin)        Co.
                               Topical Solution,
                               1.5%.

[[Page 16041]]

 
NDA 050687..................  Banan (cefpodoxime    Daiichi Sankyo,
                               proxetil) Tablets,    Inc., 399 Thornall
                               100 mg and 200 mg.    St., 11th Floor,
                                                     Edison, NJ 08837.
NDA 050688..................  Banan (cefpodoxime    Do.
                               proxetil) Granules
                               for Oral
                               Suspension, 50 mg/5
                               mL and 100 mg/5 mL.
ANDA 064098.................  Amikacin Sulfate      Hospira, Inc., 275
                               Injection USP, 250    North Field Dr.,
                               mg (base)/mL.         Bldg. H2-2, Lake
                                                     Forest, IL 60045.
ANDA 064106.................  Mitomycin for         Do.
                               Injection USP, 20
                               mg Vial.
ANDA 070505.................  Metoclopramide        Do.
                               Injection USP, 5 mg/
                               mL.
ANDA 070506.................  Metoclopramide        Do.
                               Injection USP, 5 mg/
                               mL.
ANDA 070566.................  Nitropress (sodium    Do.
                               nitroprusside for
                               Injection USP), 50
                               mg.
ANDA 071015.................  Haloperidol Oral      Teva Pharmaceuticals
                               Solution USP, 2 mg/   USA, 1090 Horsham
                               mL.                   Rd., P.O. Box 1090,
                                                     North Wales, PA
                                                     19454.
ANDA 071554.................  Thiothixene HCl Oral  Do.
                               Solution USP, 5 mg/
                               mL.
ANDA 073058.................  Fluphenazine HCl      Do.
                               Oral Solution USP,
                               5 mg/mL.
ANDA 073479.................  Pentamidine           Hospira, Inc.
                               Isethionate for
                               Injection, 300 mg
                               Vial.
ANDA 074636.................  Iopamidol Injection   Do.
                               USP, 41%, 51%, 61%,
                               76%.
ANDA 074898.................  Iopamidol Injection   Do.
                               USP, 41%, 51%, 61%,
                               76%.
ANDA 075065.................  Acyclovir Sodium for  Do.
                               Injection.
ANDA 075176.................  Haloperidol           Do.
                               Decanoate
                               Injection, 50 mg/mL
                               and 100 mg/mL.
ANDA 075409.................  Midazolam HCl         Do.
                               Injection, 1 mg
                               (base)/mL and 5 mg
                               (base)/mL.
ANDA 075884.................  Milrinone Lactate     Do.
                               Injection, 1 mg/mL.
ANDA 076306.................  Topiramate Tablets,   Roxane Laboratories,
                               25 mg, 50 mg, 100     Inc., 1809 Wilson
                               mg, and 200 mg.       Rd., Columbus, OH
                                                     43228.
ANDA 077138.................  Ciprofloxacin         Teva Pharmaceuticals
                               Injection USP in 5%   USA.
                               Dextrose Injection.
ANDA 077223.................  Terbinafine HCl       Roxane Laboratories,
                               Tablets, 250 mg       Inc.
                               (base).
ANDA 077784.................  Risperidone Tablets,  Ratiopharm Inc., c/o
                               0.25 mg, 0.5 mg, 1    Columbia Pharma
                               mg, 2 mg, 3 mg, and   Consulting Services
                               4 mg.                 Inc., 490 Northwest
                                                     Datewood Dr., Suite
                                                     400, Issaquah, WA
                                                     98027.
ANDA 078241.................  Sumatriptan           Roxane Laboratories,
                               Succinate Tablets,    Inc.
                               25 mg, 50 mg, and
                               100 mg (base).
ANDA 078318.................  Sumatriptan           TEVA Parenteral
                               Injection, 4 mg       Medicines, Inc., 19
                               (base)/0.5 mL and 6   Hughes, Irvine, CA
                               mg (base)/0.5 mL.     92618.
ANDA 078416.................  Prednisolone Sodium   Vintage
                               Phosphate Oral        Pharmaceuticals,
                               Solution, 5 mg        120 Vintage Dr.,
                               (base)/5 mL.          Huntsville, AL
                                                     35811.
ANDA 078517.................  Venlafaxine HCl       PLIVA Hrvatska
                               Tablets, 25 mg        d.o.o., c/o Barr
                               (base), 37.5 mg       Laboratories, Inc.,
                               (base), 50 mg         400 Chestnut Ridge
                               (base), 75 mg         Rd., Woodcliff
                               (base), and 100 mg    Lake, NJ 07677
                               (base).
ANDA 080997.................  Succinylcholine       Organon USA Inc.
                               Chloride Injection
                               USP, 20 mg/mL.
ANDA 081125.................  Dexamethasone Sodium  TEVA Parenteral
                               Phosphate Injection   Medicines, Inc., 19
                               USP, 4 mg/mL.         Hughes, Irvine, CA
                                                     92618.
ANDA 081126.................  Dexamethasone Sodium  Do.
                               Phosphate Injection
                               USP.
ANDA 081298.................  Chlorzoxazone         Ranbaxy Inc., U.S.
                               Tablets, 250 mg.      Agent for Ohm, 600
                                                     College Rd. East,
                                                     Princeton, NJ
                                                     08540.
ANDA 081299.................  Chlorzoxazone         Do.
                               Tablets, 500 mg.
ANDA 081310.................  Fluphenazine HCl      Teva Pharmaceuticals
                               Elixir USP, 2.5 mg/   USA.
                               5 mL.
ANDA 087005.................  Trichlormethiazide    Par Pharmaceutical,
                               Tablets, 4 mg.        Inc., One Ram Ridge
                                                     Rd., Spring Valley,
                                                     NY 10977.
ANDA 087007.................  Trichlormethiazide    Do.
                               Tablets, 2 mg.
ANDA 087032.................  Chlorpromazine HCl    Morton Grove
                               Oral Concentrate      Pharmaceuticals,
                               USP, 30 mg/mL.        Inc., U.S. Agent
                                                     for Wockhardt EU
                                                     Operations (Swiss)
                                                     AG, 6451 West Main
                                                     St., Morton Grove,
                                                     IL 60053.
ANDA 087053.................  Chlorpromazine HCl    Do.
                               Oral Concentrate
                               USP, 100 mg/mL.
ANDA 087406.................  Oxycodone and         Barr Laboratories,
                               Acetaminophen         Inc., 400 Chestnut
                               Tablets USP, 5 mg/    Ridge Rd.,
                               325 mg.               Woodcliff Lake, NJ
                                                     07677.
ANDA 087585.................  Potassium Chloride    Luitpold
                               for Injection         Pharmaceuticals,
                               Concentrate USP, 2    Inc., One Luitpold
                               mEq/mL.               Dr., P.O. Box 9001,
                                                     Shirley, NY 11967.
ANDA 088143.................  Trifluoperazine Oral  Morton Grove
                               Solution USP, 10 mg/  Pharmaceuticals,
                               mL.                   Inc., U.S. Agent
                                                     for Wockhardt EU
                                                     Operations (Swiss)
                                                     AG.
ANDA 088194.................  Thioridazine HCl      Ivax
                               Tablets USP, 50 mg.   Pharmaceuticals,
                                                     Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, 400 Chestnut
                                                     Ridge Rd.,
                                                     Woodcliff Lake, NJ
                                                     07677.
ANDA 088227.................  Thioridazine HCl      Morton Grove
                               Oral Solution USP     Pharmaceuticals,
                               (Concentrate), 100    Inc., U.S. Agent
                               mg/mL.                for Wockhardt EU
                                                     Operations (Swiss)
                                                     AG.
ANDA 088258.................  Thioridazine HCl      Do.
                               Oral Solution USP
                               (Concentrate), 30
                               mg/mL.
ANDA 088270.................  Thioridazine HCl      Ivax
                               Tablets USP, 10 mg.   Pharmaceuticals,
                                                     Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA.
ANDA 088271.................  Thioridazine HCl      Do.
                               Tablets USP, 15 mg.

[[Page 16042]]

 
ANDA 088272.................  Thioridazine HCl      Do.
                               Tablets USP, 25 mg.
ANDA 088273.................  Thioridazine HCl      Do.
                               Tablets USP, 100 mg.
ANDA 088456.................  Thioridazine HCl      Teva Pharmaceuticals
                               Tablets USP, 100 mg.  USA.
ANDA 088493.................  Thioridazine HCl      Do.
                               Tablets USP, 10 mg.
ANDA 088850.................  Hydroflumethiazide    Par Pharmaceutical,
                               Tablets USP, 50 mg.   Inc.
ANDA 088907.................  Reserpine and         Do.
                               Hydroflumethiazide
                               Tablets, 0.125 mg/
                               50 mg.
ANDA 088933.................  Sulfinpyrazone        Do.
                               Tablets, 100 mg.
ANDA 088934.................  Sulfinpyrazone        Do.
                               Capsules USP, 200
                               mg.
ANDA 089135.................  Methyclothiazide      Do.
                               Tablets, 2.5 mg.
ANDA 089136.................  Methyclothiazide      Do.
                               Tablets, 5 mg.
ANDA 089173.................  A-MethaPred           Hospira, Inc.
                               (methylprednisolone
                               sodium succinate
                               for injection USP),
                               500 mg (base)/Vial.
ANDA 089174.................  A-MethaPred           Do.
                               (methylprednisolone
                               sodium succinate
                               for injection USP),
                               1 gram (base)/Vial.
ANDA 089207.................  Methylprednisolone    Par Pharmaceutical,
                               Tablets USP, 16 mg.   Inc.
ANDA 089208.................  Methylprednisolone    Do.
                               Tablets USP, 24 mg.
ANDA 089209.................  Methylprednisolone    Do.
                               Tablets USP, 32 mg.
ANDA 089457.................  Perphenazine Tablets  Ivax
                               USP, 16 mg.           Pharmaceuticals,
                                                     Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA.
ANDA 089602.................  Thioridazine HCl      Teva Pharmaceuticals
                               Oral Solution USP,    USA.
                               30 mg/mL.
ANDA 089603.................  Thioridazine HCl      Do.
                               Oral Solution USP,
                               100 mg/mL.
ANDA 089624.................  Reversol              Organon USA Inc.
                               (edrophonium
                               chloride injection
                               USP), 10 mg/mL).
ANDA 089657.................  Methocarbamol and     Par Pharmaceutical,
                               Aspirin Tablets,      Inc.
                               400 mg/325 mg.
ANDA 089708.................  Perphenazine Tablets  Ivax
                               USP, 4 mg.            Pharmaceuticals,
                                                     Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA.
------------------------------------------------------------------------
\1\ This product included an oral pressurized metered-dose inhaler that
  contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
  longer be used as a propellant for any albuterol or salmeterol metered-
  dose inhalers (see 70 FR 17168, April 4, 2005; 71 FR 70870, December
  7, 2006).

    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and under authority 
delegated to the Director, Center for Drug Evaluation and Research, by 
the Commissioner, approval of the applications listed in table 1 in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective April 18, 2012. Introduction or delivery for 
introduction into interstate commerce of products without approved new 
drug applications violates section 301(a) and (d) of the FD&C Act (21 
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 in 
this document that are in inventory on the date that this notice 
becomes effective (see the DATES section) may continue to be dispensed 
until the inventories have been depleted or the drug products have 
reached their expiration dates or otherwise become violative, whichever 
occurs first.

    Dated: February 16, 2012.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2012-6591 Filed 3-16-12; 8:45 am]
BILLING CODE 4160-01-P