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Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 73 new drug applications (NDAs) and 62 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 DATE: December 7, 2007.

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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 6-459Hetrazan (diethylcarbamaxine citrate) Tablets and SyrupLederle Laboratories, c/o Wyeth Pharmaceuticals, Inc., P.O. Box 8299, Philadelphia, PA 19101-8299
NDA 6-799Rubramin and Rubramin PC (cyanocobalamin injection USP)Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000
NDA 7-517Tapazole (methimazole tablets USP), 5 milligrams (mg) and 10 mgKing Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620
NDA 7-942Sus-Phrine (epinephrine) InjectionForest Laboratories, Inc., Harborside Financial Center, Plaza Three, suite 602, Jersey City, NJ 07311
NDA 9-319Ambenyl Expectorant and Ambenyl Cough SyrupDo.
NDA l0-533PBZ SR (tripelennamine HCl USP) Extended-Release TabletsNovartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080
NDA 10-744Darbid (isopropamide iodide) TabletsSmithKline Beecham Corp., d/b/a/ GlaxoSmith Kline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709
NDA 10-909Miradon (anisindione) TabletsSchering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033
NDA 11-213Trilafon (perphenazine) Injection, 5 mg/milliliter (mL)Do.
NDA 11-283Kenacort (tramcinolone) TabletsBristol-Myers Squibb Co.
NDA 11-808Mellaril (thioridazine HCl) TabletsNovartis Pharmaceuticals Corp.
NDA 12-145Prolixin (fluphenazine HCl) Elixir, 0.5 mg/mLApothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500
NDA 12-313BIO-CLEAR (dibenzothiophene) CreamHelena Rubinstein, 202 Rodney Bldg., 3411 Silverside Rd., Wilmington, DE 19810
NDA 12-665Velban (vinblastine sulfate) for InjectionEli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285
NDA 12-678Tolbutamide TabletsSandoz Inc., 227-15 North Conduit Ave., Laurelton, NY 11413
NDA 12-796Quinidex Extentabs (quinidine sulfate extended-release tablets USP)Wyeth Pharmaceuticals, Inc.
NDA 14-103Oncovin (vincristine sulfate) InjectionEli Lilly and Co.
NDA 14-242Dexacort (dexamethasone sodium phosphate) TurbinaireUCB, 755 Jefferson Rd., Rochester, NY 14623
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NDA 14-262Solbar (dioxybenzone and oxybenzone) CreamPerson & Covey, Inc., 616 Allen Ave., Glendale, CA 91201
NDA 16-363Lasix (furosemide) 10-mg/mL InjectionSanofi-Aventis, 300 Somerset Corporate Blvd., Bridgewater, NJ 08807-0977
NDA 16-408WILDROOT (pyrithione zinc) Hair Groom and Grenadier Hair GroomColgate-Palmolive Co., 909 River Rd., Piscataway, NJ 08854-5596
NDA 16-729Ferrous Citrate Fe 59 InjectionMallinckrodt Inc., 675 McDowell Blvd., P.O. Box 5840, St. Louis, MO 63134
NDA 16-820Emete-Con (benzquinamide HCl) InjectionPfizer, Inc., 235 East 42nd St., New York, NY 10017
NDA 16-847Isopaque 440 (metrizoate sodium, meglumine metrizoate, calcium metrizoate, and metrizoate magnesium) InjectionGE Healthcare, 101 Carnegie Center, Princeton, NJ 08540
NDA 17-430Neggram (nalidixic acid USP) SuspensionSanofi-Aventis
NDA 17-466Bricanyl (terbutaline sulfate) InjectionSanofi-Aventis
NDA 17-506Isopaque 280 (metrizoic acid, meglumine, and calcium) InjectionGE Healthcare
NDA 17-613Lotrimin (clotrimazole) Topical Solution, 1%Schering Corp.
NDA 17-618Bricanyl (terbutaline sulfate) TabletsSanofi-Aventis
NDA 17-619Lotrimin (clotrimazole) Cream, 1%Schering Corp.
NDA 17-668Tenuate (diethylpropion HCl) Tablets, 25 mgSanofi-Aventis
NDA 17-669Tenuate (diethylpropion HCl) Extended-Release Tablets, 75 mgSanofi-Aventis
NDA 17-688Lasix (furosemide) Oral Solution, 10 mg/mLSanofi-Aventis
NDA 17-719Dimeray (iocarmate meglumine) InjectionMallinckrodt Inc.
NDA 17-725Sodium Pertechnetate Tc-99m (technectium Tc-99m sodium pertechnetate)Mallinckrodt Inc.
NDA 17-730Isopaque 370 (metrizoic acid and meglume) InjectionGE Healthcare
NDA 17-769Calcimar (calcitonin salmon) InjectionSanofi-Aventis
NDA 17-838Lungaggregate ReagentGE Healthcare
NDA 17-848Tc-99m LungaggregateDo.
NDA 17-907Glucoscan Kit for the Preparation of Technetium Tc-99m GluceptateBristol-Myers Squibb Pharma Co., Chestnut Run Plaza, 974 Centre Rd., Wilmington, DE 19805
NDA 17-923Mellaril-S (thioridazine HCl) Oral SuspensionNovartis Pharmaceuticals Corp.
NDA 17-956Tepanil (diethylpropion HCl) Ten-Tabs3M Pharmaceuticals, 3M Center, Bldg 0275-05-W-12, St. Paul, MN 55144-1000
NDA 18-000Bricanyl (terbutaline sulfate) InhalerSanofi-Aventis
NDA 18-067Cinobac (cinoxacin) Capsules, 250 mg and 500 mgEli Lilly and Co.
NDA 18-088Krypton Kr-81m Gas GeneratorGE Healthcare
NDA 18-148Nasalide (flunisolide) Nasal SprayIVAX Research, Inc., 4400 Biscayne Blvd., Miami, FL 33137
NDA 18-489Technescan HIDA (kit for the preparation of technetium Tc-99m lidofenin injection)Draximage, 16751 Autoroute TransCanada Highway, Kirkland, Quebec, H9H 4J4, Canada
NDA 18-519Irrigation Solution G (citric acid and sodium carbonate)Baxter Healthcare Corp., 1620 Waukegan Rd., MPGR-AL, McGaw Park, IL 60085
NDA 18-554Eulexin (flutamide) CapsulesSchering Corp.
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NDA 18-700Inocor (inamrinone lactate) Injection, 5 mg base/mLSanofi-Synthelabo Inc., c/o Sanofi-Aventis, 300 Somerset Corporate Blvd., P.O. Box 6977, Bridgewater, NJ 08807-0977
NDA 18-770Tornalate (bitolterol mesylate) Metered-Dose InhalerSanofi-Aventis
NDA 18-813Lotrimin (clotrimazole) Lotion, 1%Schering Corp.
ANDA 18-862Betatrex (betamethasone valerate cream USP, 0.1%)Savage Laboratories, 60 Baylis Rd., Melville, NY 11747
ANDA 18-863Betatrex (betamethasone valerate ointment USP, 0.1%)Do.
ANDA 18-867Betatrex (betamethasone valerate lotion USP, 0.1%)Do.
NDA 19-084Nizoral (ketoconazole) Cream, 2%Johnson & Johnson Pharmaceutical Research & Development, LLC, c/o Janssen Pharmaceutical Products, LP, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560
NDA 19-284Oral Colonic Lavage (OCL) (sodium chloride, sodium bicarbonate, sodium sulfate, potassium chloride, and polyethelene glycol 3350)Hospira, Inc., 275 North Field Dr., Bldg. 2-J45-2, Lake Forest, Il 60045-5046
NDA 19-408Diprolene (betamethasone dipropionate)Schering Corp.
NDA 19-459Photoplex (7% padimate O and 3% avobenzone) LotionAllergan, 2525 Dupont Dr., P.O. Box 19534, Irvine, CA 92623-9534
NDA 19-520Travasol (amino acid) in Dextrose InjectionBaxter Healthcare Corp.
NDA 19-545Didronel (etidronate disodium) InjectionMGI Pharma, Inc., 5775 West Old Shakopee Rd., suite 100, Bloomington, MN 55437-3174
NDA 19-548Tornalate (bitolterol mesylate) Inhalatioon Solution, 0.2%Sanofi-Aventis
NDA 19-576Nizoral (ketoconazole) Cream, 2%Johnson & Johnson Pharmaceutical & Development, LLC
NDA 19-648Nizoral (ketoconazole) Cream, 2%Do.
NDA 20-091Imagent (perflubron)Alliance Pharmaceuticals Corp., 4660 La Jolla Dr., suite 740, San Diego, CA 92122
NDA 20-147Travasol (amino acid) with Electrolytes in Dextrose InjectionBaxter Healthcare Corp.
NDA 20-228Atrovent (ipratropium bromide) Inhalation SolutionBoehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. Box 368, Ridgefield, CT 06877-0368
NDA 20-303Prempro/Premphase (conjugated estrogens and medroxyprogesterone acetate) TabletsWyeth Pharmaceuticals, Inc.
NDA 20-315Orlaam (levomethadyl acetate HCl) Oral SolutionRoxane Laboratories, P.O. Box 16532, Columbus, OH 43216-6532
NDA 20-486Vanceril (beclomethasone dipropionate) Double Strength AerosolSchering Corp.
NDA 20-887AcuTect Kit for the Preparation of Technetium Tc-99m Apticide InjectionCIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730
NDA 21-012Neo-Tect Kit for the Preparation of Technetium Tc-99m Depreotide InjectionDo.
NDA 21-075Nutropin Depot (somatropin recombinant)Genentech Inc., 1 DNA Way MS#242, South San Francisco, CA 94080-4990
ANDA 40-098Acetaminophen and Codeine Phosphate Oral Solution USPClonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512
NDA 50-477Nebcin (tobramycin sulfate) for InjectionEli Lilly and Co.
NDA 50-519Nebcin (tobramycin sulfate) for InjectionDo.
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NDA 50-678Dynabac (dirithromycin delayed-release tablets USP)Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285
ANDA 60-212Grisactin (griseofulvin microcrystalline) Tablets, 500 mgWyeth Ayerst Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101
ANDA 60-570Fungizone (amphotericin B lotion USP), 3%Apothecon, c/o Bristol-Myers Squibb Co.
ANDA 60-751NEO-CORTEF (neomycin sulfate and hydrocortisone acetate) OintmentPharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42nd St., New York, NY 10017
ANDA 61-007Terramycin (oxytetracycline HCl, polymyxin B sulfate) Topical Ointment with Polymyxin B SulfatePfizer, Inc.
ANDA 61-131Nystatin Powder USPClonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.
ANDA 61-411Veetids (penicillin V potassium tablets USP), 250 mg and 500 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 61-737ZIBA-Rx (bacitracin zinc USP)X-GEN Pharmaceuticals, Inc., P.O. Box 1148, Elmira, NY 14902
ANDA 61-859Anspor (cephradine) Capsules, 250 mg and 500 mgGlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929
ANDA 61-866Anspor (cephradine) for Oral SuspensionDo.
ANDA 61-876Cerubidine Injection (daunorubice HCl for injection USP)Sanofi-Aventis
ANDA 62-519Nystex (nystatin) Oral Suspension USP, 100,000 units/mLSavage Laboratories
ANDA 62-560Mandol (cefamadole nafate for injection USP)Eli Lilly and Co.
ANDA 62-739Tazidime (ceftazidime)Do.
ANDA 62-745Cephalexin Tablets USPDo.
ANDA 62-888Principen (ampicillin capsules USP), 250 mg and 500 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 62-926Rubex (doxorubicin HCl for injection USP)Bristol-Myers Squibb Co.
ANDA 63-021Kanamycin Sulfate Injection USP, 75 mg/2 mLLoch Pharmaceuticals, c/o Bedford Laboratories, A Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146
ANDA 63-022Kanamycin Sulfate Injection USP, 500 mg/2 mLDo.
ANDA 63-025Kanamycin Sulfate Injection USP, 1 gram (g)/3 mLDo.
ANDA 63-099Trimox (amoxicillin capsules USP), 250 mg and 500 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 70-867Vincrex (vincristine sulfate for injection USP), 5 mg/vialBristol-Myers Squibb Co.
ANDA 71-742Clorazepate Dipotassium Capsules, 3.75 mgClonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.
ANDA 71-743Clorazepate Dipotassium Capsules, 7.5 mgDo.
ANDA 71-744Clorazepate Dipotassium Capsules, 15 mgDo.
ANDA 72-326Fenoprofen Calcium Tablets USP, 600 mgDo.
ANDA 72-507Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15 mgDo.
ANDA 72-508Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25 mgDo.
ANDA 72-509Methyldopa and Hydrochlorothiazide Tables USP, 500 mg/30 mgDo.
ANDA 72-510Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50 mgDo.
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ANDA 72-705Prazosin HCl Capsules USP, 1 mgDo.
ANDA 72-706Prazosin HCl Capsules USP, 2 mgDo.
ANDA 72-707Prazosin HCL Capsules USP, 5 mgDo.
ANDA 74-258Metoprolol Tartrate Tablets USP, 50 mg and 100 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 74-423Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mgClonmel Healthcare, Ltd., c/o of STADA Pharmaceuticals Inc.
ANDA 74-472Captopril Tablets USP, 12.5 mg, 25 mg, 50 mg, and 100 mgApothecon, c/o Bristol-Myers Squibb Co.
ANDA 75-407Morphine Sulfate Extended-Release Tablets USP, 15 mgClonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.
ANDA 80-745Aristocort (triamcinolone acetonide) Ointment, 0.5%Astellas Pharma US, Inc., Three Parkway North, Deerfield, IL 60015-2537
ANDA 80-750Aristocort (triamcinolone acetonide) Ointment, 0.1%Do.
ANDA 83-015Aristocort (triamcinolone acetonide) Cream, 0.5%Do.
ANDA 83-016Aristocort (triamcinolone acetonide) Cream, 0.1%Do.
ANDA 83-017Aristocort (triamcinolone acetonide) Cream, 0.025%Do.
ANDA 83-149PBZ (tripelennamine HCl) Tablet, 25 mgNovartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936-1080
ANDA 83-317Propoxyphene HCl Capsules, 65 mgImpax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544
ANDA 83-380Aristogel (triamcinolone acetonide) Gel, 0.1%Astellas Pharma US, Inc.
ANDA 83-881Aristocort A (triamcinolone acetonide) SprayDo.
ANDA 86-212Chlordiazepoxide HCl Capsules, 25 mgImpax Laboratories, Inc.
ANDA 86-213Chlordiazepoxide Capsules, 5 mgDo.
ANDA 86-358Mexate (methotrexate sodium for injection)Bristol-Myers Squibb Co.
ANDA 86-926Tolbutamide Tablets USP, 500 mgClonmel Healthcare, Ltd., c/o STADA Pharmaceuticals Inc.
ANDA 87-011Quinidine Sulfate Tablets USP, 200 mgDo.
ANDA 87-677Hydrocodone Bitartrate and AcetaminophenB.F. Ascher & Co., Inc., 15501 West 109th St., Lenexa, KS 66219
ANDA 87-887TRYSUL (triple sulfa vaginal cream USP)Savage Laboratories
ANDA 88-584DHC Plus (dihydrocodeine bitartrate, acetaminophen, and caffeine) CapsulesThe Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431
ANDA 88-760Mexate-AQ (methotrexate sodium injection USP), 25 mgBristol-Myers Squibb Co.
ANDA 88-780Aristocort A Ointment (triamcinolone acetonide ointment USP), 0.1%Astellas Pharma US, Inc.
ANDA 88-781Aristocort A (triamcinolone acetonide) Ointment, 0.5%Do.
ANDA 88-944Sedapap (butalbital and acetaminophen) Tablets, 50 mg/650 mgMerz Pharmaceuticals, LLC, 4215 Tudor Lane, Greensboro, NC 27410
ANDA 89-887Mexate-AQ Preserved (methotrexate sodium injection USP), 25 mg/mLBristol-Myers Squibb 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, approval of the applications listed in the table in this document, and all amendments and Start Printed Page 62863supplements thereto, is hereby withdrawn, effective December 7, 2007.

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Dated: October 26, 2007.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. E7-21886 Filed 11-6-07; 8:45 am]