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Merck & Co., Inc., et al.; Withdrawal of Approval of 65 New Drug Applications and 52 Abbreviated New Drug Applications

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 65 new drug applications (NDAs) and 52 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective June 16, 2006.

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Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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The holders of the applications listed in the table in this document have informed FDA that these drug products are no longer marketed and have requested that FDA withdraw approval of the applications. The applicants have also, by their requests, waived their opportunity for a hearing.

Application No.DrugApplicant
NDA 1-645Vitamin B6 (pyridoxine hydrochloride (HCl))Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486-0004
NDA 5-521Heparin Sodium Injection USPEli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 5-657Tubocurarine Chloride Injection USPBristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500
NDA 5-794Sultrin Triple Sulfa Cream and Triple Sulfa TabletsOrtho-McNeil Pharmaceutical, Inc., 1000 U.S. Highway 202, P.O. Box 300, Raritan, NJ 08869-0602
NDA 6-012Folvron (folic acid and iron)Lederle Laboratories, 401 North Middleton Rd., Pearl River, NY 10965
NDA 7-149Rubramin (cyanocobalamin) Tablets and CapsulesBristol-Myers Squibb Co.
NDA 7-504Acthar (corticotropin for injection)Aventis Pharmaceuticals, Inc., 200 Crossing Blvd., BX 2-309E, Bridgewater, NJ 08807
NDA 7-794Neothylline (dyphylline)Teva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454
NDA 9-176Cortril (hydrocortisone) Topical OintmentPfizer Global Pharmaceuticals, 235 East 42nd St., New York, NY 10017
NDA 10-028Equanil (meprobamate) TabletsWyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 10-093Biphetamine (dextroamphetamine and amphetamine) CapsulesCelltech Pharmaceuticals, Inc., 755 Jefferson Rd., P.O. Box 31710, Rochester, NY 14603
NDA 10-513Ketonil (amino acids and electrolytes)Merck & Co., Inc.
NDA 10-787Iron Dextran InjectionAventis Pharmaceuticals, Inc.
NDA 10-799Dimetane (brompheniramine maleate) Tablets and ExtendtabsWyeth Consumer Healthcare, 5 Giralda Farms, Madison, NJ 07940
NDA 11-340Cerumenex (triethanolamine polypeptide oleate-condensate), 10%The Purdue Frederick Co., 1 Stamford Forum, Stamford, CT 06901-3431
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NDA 11-960Aristocort (triamcinolone diacetate) SyrupAstellas Pharma US, Inc., 3 Parkway North, Deerfield, IL 60015-2548
NDA 11-984Decadron Phosphate (dexamethasone sodium phosphate) Sterile Ophthalmic SolutionMerck & Co., Inc.
NDA 12-122Glucagon (glucagon HCl) for InjectionEli Lilly & Co.
NDA 12-281Robaxisal (methocarbamol USP and aspirin USP) TabletsA.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 12-649Periactin (cyproheptadine HCl)Merck & Co., Inc.
NDA 12-703Elavil (amitriptyline HCl) TabletsAstraZeneca Pharmaceuticals, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355
NDA 12-704Elavil (amitriptyline HCl) InjectionDo.
NDA 13-220Periactin (cyproheptadine HCl) Syrup, 2 milligrams (mg)/5 milliliters (mL)Merck & Co., Inc.
NDA 13-400Aldomet (methyldopa) TabletsDo.
NDA 13-401Aldomet (methyldopate HCl) Injection, 50 mg/mLDo.
NDA 13-413Dexacort Phosphate (dexamethasone sodium phosphate) in RespihalerCelltech Pharmaceuticals, Inc.
NDA 16-016Aldoclor-150 and -250 (methyldopa and chlorothiazide) Tablets, 250 mg/150 mg and 250 mg/250 mgMerck & Co., Inc.
NDA 16-030Bayer 8 Hour Aspirin and Measurin Aspirin (aspirin extended-release tablets), 650 mgBayer Healthcare, LLC, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962-1910
NDA 16-099Atromid-S (clofibrate) CapsulesWyeth Pharmaceuticals
NDA 16-745Jergens Antibacterial Deodorant (triclocarban, 1%) SoapKao Brands Co., 2535 Springs Grove Ave., Cincinnati, OH 45214-1773
NDA 16-888Selsun Blue (selenium sulfide) Cream/Shampoo, 1%Abbott Laboratories, 625 Cleveland Ave., Columbus, OH 43215-1724
NDA 17-569Renoquid (sulfacytine) TabletsGlenwood LLC, 111 Cedar Lane, Englewood, NJ 07631
NDA 17-573Vanceril (beclomethasone dipropionate) Inhalation AerosolSchering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 17-659Alupent (metaproterenol sulfate) Inhalation Solution, 5%Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368
NDA 17-781Diprosone (betamethasone dipropionate) LotionSchering Corp.
NDA 17-820Dobutrex (dobutamine HCl) Sterile InjectionEli Lilly & Co.
ANDA 18-023Lactated Ringer's Injection USPB. Braun Medical, Inc., 2525 McGaw Ave., P.O. Box 19791, Irvine, CA 92623-9791
ANDA 18-0265% Dextrose and 0.9% Sodium Chloride (NaCl) InjectionDo.
ANDA 18-04610% Dextrose Injection USPDo.
ANDA 18-04710% Dextrose and 0.9% NaCl Injection USPDo.
ANDA 18-1840.45% NaCl Injection USPDo.
ANDA 18-1861/6 Molar Sodium Lactate Injection USP in Plastic ContainerDo.
ANDA 18-197Ibuprofen TabletsBASF Corp., 8800 Line Ave., Shreveport, LA 71106
ANDA 18-252Isolyte S (multi-electrolyte injection) InjectionB. Braun Medical, Inc.
ANDA 18-2565% Dextrose in Ringer's InjectionDo.
NDA 18-257Tonocard (tocainide HCl) Tablets, 400 mg and 600 mgAstraZeneca Pharmaceuticals
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ANDA 18-274Isolyte S (multi-electrolyte injection) with 5% Dextrose in Plastic ContainerB. Braun Medical, Inc.
NDA 18-389Aldomet (methyldopa) Oral Suspension, 250 mg/5 mLMerck & Co., Inc.
NDA 18-682TZ-3 (1% tioconazole) Dermal CreamPfizer, Inc., 235 East 42nd St., New York, NY 10017
NDA 18-686Normodyne (labetalol HCl USP) Injection, 5 mg/mLSchering Corp.
NDA 18-687Normodyne (labetalol HCl USP) TabletsDo.
ANDA 18-721Ringer's Injection USPB. Braun Medical, Inc.
NDA 18-754Orudis (ketoprofen) Capsules, 25 mg, 50 mg, and 75 mgWyeth Pharmaceuticals
NDA 18-792Neopham (amino acids) InjectionHospira, Inc., 275 North Field Dr., Dept. 389, Bldg. 2, Lake Forest, IL 60045
NDA 18-901Aminess (essential amino acids injection with histidine)Do.
NDA 18-911Heparin Sodium in 5% Dextrose Injection and Heparin Sodium in NaCl InjectionDo.
NDA 19-083Theophylline and 5% Dextrose InjectionB. Braun Medical, Inc.
NDA 19-107Protropin (somatrem) for InjectionGenentech, Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990
ANDA 19-138Alphatrex (betamethasone dipropionate cream USP) 0.05%Savage Laboratories, 60 Baylis Rd., Melville, NY 11747
ANDA 19-143Alphatrex (betamethasone dipropionate ointment USP) 0.05%Do.
NDA 19-383Proventil (albuterol sulfate extended-release tablets USP) RepetabsSchering Corp.
NDA 19-401Pseudo-12 Suspension (pseudoephedrine polistirex extended-release suspension)Celltech Pharmaceuticals, Inc.
NDA 19-523Cysteine HCl Injection USP, 7.25%Hospira, Inc.
NDA 19-589Vancenase AQ (beclomethasone dipropionate) Nasal SpraySchering Corp.
NDA 19-621Ventolin (albuterol sulfate) SyrupGlaxoSmithKline Pharmaceuticals, 5 More Dr., P.O. Box 13358, Research Triangle Park, NC 27709
NDA 20-035Ergamisol (levamisole HCl) TabletsJohnson & Johnson Pharmaceutical Research and Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., K1-02B, Titusville, NJ 08560-0200
NDA 20-176VitaPed (multivitamins)Hospira, Inc.
NDA 20-338Differin (adapalene) Solution, 0.1%Galderma Laboratories, LP, 14501 North Freeway, Fort Worth, TX 76177
NDA 20-759Trovan (trovafloxacin mesylate) Tablets, 100 mg and 200 mgPfizer, Inc.
NDA 20-760Trovan (alatrofloxacin mesylate) InjectionDo.
NDA 20-847Esclim (estradiol extended-release film) Transdermal SystemWomen First Healthcare, Inc., 380 Lexington Ave., New York, NY 10168
NDA 20-962Emla (2.5% lidocaine and 2.5% prilocaine) Anesthetic DiscAstraZeneca Pharmaceuticals
ANDA 40-023Adrucil (fluorouracil injection USP), 50 mg/mLSicor Pharmaceuticals, Inc., 19 Hughes, Irvine, CA 92618
ANDA 40-147Leucovorin Calcium Injection USP, 10 mg (base)/mLHospira, Inc.
NDA 50-039Garamycin (gentamicin sulfate) Ophthalmic SolutionSchering Corp.
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NDA 50-091Chloroptic (chloramphenicol ophthalmic solution USP), 0.5%Allergan, Inc., 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534
NDA 50-322Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Sterile Ophthalmic SolutionMerck & Co., Inc.
NDA 50-368Ilotycin (erythromycin) Ophthalmic OintmentEli Lilly & Co.
NDA 50-571CefMax (cefmenoxime HCl) InjectionTAP Pharmaceutical Products, Inc., 675 North Field Dr., Lake Forest, IL 60045
NDA 50-648Clindamycin Phosphate Injection in 5% DextroseBaxter Healthcare Corp., Route 120 & Wilson Rd., Round Lake, IL 60073
ANDA 60-429Sumycin Capsules (tetracycline HCl capsules USP)Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500
ANDA 62-480Gentacidin Solution (gentamicin sulfate ophthalmic solution USP)Novartis Pharmaceuticals Corp., 1 Health Plaza, Bldg. 118, East Hanover, NJ 07936-1080
ANDA 62-597Mytrex (nystatin and triamcinolone acetonide cream USP) 100,000 units/gram (g) and 1 mg/gSavage Laboratories
ANDA 62-601Mytrex (nystatin and triamcinolone acetonide ointment USP) 100,000 units/g and 1 mg/gDo.
ANDA 62-750Pipracil (piperacillin for injection), 2 g, 3 g, and 4 gWyeth Pharmaceuticals, Inc.
ANDA 63-186Cephalexin Capsules USP, 250 mg and 500 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 64-084Sterile Bleomycin Sulfate for Injection USP, 15 and 30 units/vialSicor Pharmaceuticals, Inc.
ANDA 70-083Ibuprofen Tablets USP, 400 mgBASF Corp.
ANDA 70-099Ibuprofen Tablets USP, 600 mgDo.
ANDA 70-273Alphatrex (betamethasone dipropionate lotion USP), 0.05%Savage Laboratories
ANDA 70-745Ibuprofen Tablets USP, 800 mgBASF Corp.
ANDA 72-621Acetylcysteine Solution USP, 10%Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216
ANDA 72-622Acetylcysteine Solution USP, 20%Do.
ANDA 72-995Metoclopramide HCl Oral Solution, 10 mg/mLDo.
ANDA 73-562Diflunisal Tablets USP, 250 mgDo.
ANDA 73-563Diflunisal Tablets USP, 500 mgDo.
ANDA 74-166Toposar (etoposide injection USP), 20 mg/mLSicor Pharmaceuticals, Inc.
ANDA 74-541Cimetidine HCl Oral Solution, 30 mg/5 mLRoxane Laboratories, Inc.
ANDA 74-663Acyclovir Sodium for Injection USP, 500 mg base/vial and 1 g base/vialHospira, Inc.
ANDA 75-179Nabumetone TabletsCopley Pharmaceutical, Inc., 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454
ANDA 75-875Carbamazepine Oral Suspension USP, 100 mg/5 mLTaro Pharmaceutical Industries, Ltd., c/o Taro Pharmaceuticals, U.S. Agent, 5 Skyline Dr., Hawthorne, NY 10532
ANDA 80-643Diphenhydramine HCl Elixir USP, 25 mg/10 mLRoxane Laboratories, Inc.
ANDA 81-225Adrucil (etopside injection USP), 50 mg/mLSicor Pharmaceuticals, Inc.
ANDA 83-261Pentobarbital Sodium Injection USPWyeth Pharmaceuticals
ANDA 83-383Diucardin (hydroflumethiazide tablets USP) Tablets, 50 mgDo.
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ANDA 84-015Bleph-10 (sulfacetamide sodium ophthalmic ointment USP) Ophthalmic Ointment, 10%Allergan, Inc.
ANDA 84-514Dilor (dyphylline tablets USP), 200 mgSavage Laboratories
ANDA 84-751Dilor-400 (dyphylline tablets USP), 400 mgDo.
ANDA 85-035Diphenoxylate HCl and Atropine Sulfate Tablets USP, 2.5 mg and 0.025 mgR & S Pharma, LLC, 8407 Austin Tracy Rd., Fountain Run, KY 42133
ANDA 85-961Methocarbamol Tablets USP, 500 mgClonmel Healthcare Ltd., c/o STADA Pharmaceuticals, Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512
ANDA 85-963Methocarbomal Tablets USP, 750 mgDo.
ANDA 86-899Isoetharine HCl Inhalation Solution USP, 1%Roxane Laboratories, Inc.
ANDA 87-450Chlorthalidone Tablets USP, 50 mgClonmel Healthcare Ltd.
ANDA 87-451Chlorthalidone Tablets USP, 25 mgDo.
ANDA 87-500Aminophylline Tablets USP, 100 mgRoxane Laboratories, Inc.
ANDA 87-501Aminophylline Tablets USP, 200 mgDo.
ANDA 88-253T-Phyl (theophylline) Extended-Release Tablets, 200 mgThe Purdue Frederick Co.

Therefore, under section 505(e), of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)), and under authority delegated to the Director, Center for Drug Evaluation and Research, by the Commissioner of Food and Drugs, approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective June 16, 2006.

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Dated: May 23, 2006.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. E6-9440 Filed 6-15-06; 8:45 am]