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Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is withdrawing approval of 92 new drug applications (NDAs) and 49 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 18, 2009.

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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.

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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.Start Printed Page 23408

Application No.DrugApplicant
NDA 6-403Priscoline (tolazoline hydrochloride (HCl)Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ 07936-1080
NDA 8-303Apresoline (hydralazine HCl)Do.
NDA 9-087Hydergine (ergoloid mesylates) Sublingual TabletsDo.
NDA 9-509Aramine (metaraminol bitartrate) Injection, 10 milligrams (mg)/milliliter (mL)Merck & Co., Inc., UG2C-50, P.O. Box 1000, North Wales, PA 19454-1099
NDA 9-987Delta-Cortef (prednisolone) TabletsPharmacia & Upjohn Co., c/o Pfizer, Inc., 235 East 42d St., New York, NY 10017
NDA 10-060Florinef (fludrocortisone acetate) TabletsKing Pharmaceuticals, Inc., 501 5th St., Bristol, TN 37620
NDA 10-392Atarax (hydroxyzine HCl) TabletsPfizer, Inc., 235 East 42d St., New York, NY 10017
NDA 10-485Atarax (hydroxyzine HCl) SyrupRoerig Pharmaceuticals, c/o Pfizer, Inc.
NDA 10-571Compazine (prochlorperazine maleate) TabletsGlaxoSmithKline, 1250 South Collegeville Rd., UP4110, Collegeville, PA 19426
NDA 10-611Halotestin (fluoxymesterone) Tablets, 2 mg, 5 mg, and 10 mgPharmacia & Upjohn Co., c/o Pfizer, Inc.
NDA 10-686Moderil (rescinnamine) Tablets, 0.25 mg and 0.5 mgPfizer, Inc.
NDA 10-742Compazine (prochlorperazine edisylate) InjectionGlaxoSmithKline
NDA 10-976Enovid/Enovid-E/Enovid-E 21 (norethynodrel and mestranol) TabletsG.D. Searle LLC, c/o Pfizer, Inc.
NDA 11-000Compazine (prochlorperazine maleate) Extended-Release CapsulesGlaxoSmithKline
NDA 11-111Vistaril (hydroyzine HCl) InjectionPfizer, Inc.
NDA 11-127Compazine (prochlorperazine) SuppositoriesGlaxoSmithKline
NDA 11-188Compazine (prochlorperazine edisylate) SyrupDo.
NDA 11-556Anturane (sulfinpyrazone) Tablets and CapsulesNovartis Pharmaceuticals Corp.
NDA 11-635Diupres (chlorothiazide and reserpine) TabletsMerck & Co., Inc.
NDA 11-793Esidrix (hydrochlorothiazide) TabletsNovartis Pharmaceuticals Corp.
NDA 11-838Tofranil (imipramine HCl) InjectionDo.
NDA 12-193Ser-Ap-Es (reserpine, hydralazine HCl, and hydrochlorothiazide) TabletsDo.
NDA 12-329Ismelin (guanethidine monosulfate) TabletsDo.
NDA 12-753Torecan (thiethylperazine maleate) Tablets, 10 mgDo.
NDA 12-754Torecan (thiethylperazine maleate) Injection, 5 mg/mLDo.
NDA 12-791Hypertensin (angiotensin amide) InjectionDo.
NDA 12-845Renese (polythiazide) Tablets, 1 mg, 2 mg, and 4 mgPfizer, Inc.
NDA 13-636Renese-R (polythiazide and reserpine) Tablets, 2 mg/0.25 mgDo.
NDA 15-500Tolinase (tolazamide) TabletsPharmacia & Upjohn Co., c/o Pfizer, Inc.
NDA 16-029Ovulen (ethynodiol diacetate and mestranol) TabletsG.D. Searle LLC, c/o Pfizer, Inc.
NDA 16-126Primatene (epinephrine bitartrate) Mist, 0.2 mg, and Bronitin (epinephrine bitartrate) Mist, 0.3 mgWyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940
NDA 16-635Cyanocobalamin CO-57 Schilling Test KitMallinckrodt Medical, c/o Mallinckrodt, Inc., 675 McDonnell Blvd., Hazelwood, MO 63042
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NDA 16-705Ovulen-28 (ethynodiol diacetate and mestranol) TabletsG.D. Searle LLC, c/o Pfizer, Inc.
NDA 16-709Ortho-Novum 1/50-28 (norethindrone and mestranol) TabletsOrtho-McNeil-Janssen Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC, 920 Rt. 202, P.O. Box 300, Raritan, NJ 08869
NDA 16-758Navane (thiothixene HCl) Oral ConcentratePfizer, Inc.
NDA 16-834Lithane (lithium carbonate) TabletsDo.
NDA 16-904Navane (thiothixene HCl) InjectionDo.
NDA 17-059TechneColl (technetium Tc-99m sulfur colloid kit)Mallinckrodt Medical, c/o Mallinckrodt, Inc.
NDA 17-247Sanorex (mazindol) TabletsNovartis Pharmaceuticals Corp.
NDA 17-476Slow-K (potassium chloride) Extended-Release TabletsDo.
NDA 17-543Ludiomil (maprotiline HCl) Tablets, 25 mg, 50 mg, and 75 mgNovartis Pharmaceuticals Corp.
NDA 17-551Perchloracap (potassium perchlorate) CapsulesMallinckrodt Medical, c/o Mallinckrodt, Inc.
NDA 17-842TechneScan MAA (technetium Tc-99m albumin aggregate kit)Do.
NDA 17-844Radioiodinated Serum Albumin (Human) IHSA I-125 (iodinated I-125 albumin injection)Do.
NDA 17-851Lioresal (baclofen) Tablets, 10 mg and 20 mgNovartis Pharmaceuticals Corp.
NDA 17-971Eskalith (lithium carbonate) Tablets, 300 mgJDS Pharmaceuticals, LLC, c/o Noven Pharmaceuticals, Inc., 11960 SW. 44th St., Miami, FL 33186
NDA 17-986Minizide (prazosin HCl and polythiazide) Capsules, 1 mg, 2 mg, and 5 mgPfizer, Inc.
NDA 18-006Meclomen (meclofenamate sodium) Capsules, 50 mg and 100 mgParke-Davis, a subsidiary of Pfizer, Inc.
NDA 18-152Eskalith CR (lithium carbonate) Controlled-Release Tablets, 450 mgJDS Pharmaceuticals, LLC, c/o Noven Pharmaceuticals, Inc.
NDA 18-202Cytadren (aminoglutethimide) TabletsNovartis Pharmaceuticals Corp.
NDA 18-245Syntocinon (oxytocin) InjectionDo.
NDA 18-249Sodium Lactate Injection USPHospira, Inc., 275 North Field Dr., Lake Forest, IL 60045-5046
NDA 18-272Technescan Gluceptate (technetium Tc-99m gluceptate kit)Draximage, a division of DRAXIS Specialty Pharmaceuticals, Inc., 16751 Autoroute TransCanada Highway, Kirkland, Qu. Canada H9H 4J4
NDA 18-285Visken (prindolol) TabletsNovartis Pharmaceuticals Corp.
NDA 18-535Diulo (metolazone) Tablets, 2.5 mg, 5 mg, and 10 mgG.D. Searle LLC, c/o Pfizer, Inc.
NDA 18-536Xenon Xe-127 GasMallinckrodt, Inc.
NDA 18-904Urologic G (citric acid, sodium carbonate, and magnesium oxide) Irrigation in Plastic ContainersHospira, Inc.
NDA 19-650Flumadine (rimantadine HCl) SyrupForest Laboratories, Inc., Harborside Financial Center III, suite 602, Jersey City, NJ 07311
NDA 19-672Efidac 24 Pseudoephedrine/Brompheniramine (pseudoephedrine HCl and brompheniramine maleate) Extended-Release TabletsAlza Corp., 1900 Charleston Rd., P.O. Box 7210, Mountain View, CA 94039-7210
NDA 19-721Norditropin (somatropin recombinant) for InjectionNovo Nordisk Inc., 100 College Rd. West, Princeton, NJ 08540
NDA 19-746Efidac 24 Chlorpheniramine (chlorpheniramine maleate) Extended-Release TabletsAlza Corp.
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NDA 19-753Ethmozine (moricizine HCl) TabletsShire Development, Inc., 725 Chesterbrook Blvd., Wayne, PA 19087
NDA 19-762Testoderm (testosterone) and Testoderm with AdhesiveAlza Corp.
NDA 19-775Minipress XL (prazosin HCl) Extended-Release TabletsPfizer, Inc.
NDA 19-794Depakote CP (divalproex sodium) Delayed-Release TabletsAbbott Laboratories, 200 Abbott Park Rd., Abbott Park, IL 60664-6157
NDA 19-863Geref Diagnostic (sermorelin acetate) for InjectionEMD Serono, Inc., One Technology Dr., Rockland, MA 02370
NDA 19-983Prostep (nicotine) Transdermal System, 11 mg/24 hour (h) and 22 mg/24 hAveva Drug Delivery Systems, Inc., 3250 Commerce Pkwy., Miramar, FL 33025
NDA 20-013Maxaquin (lomefloxacin HCl) TabletsPharmacia & Upjohn Co., c/o Pfizer, Inc.
NDA 20-044Exosurf Neonatal (colfosceril palmitate, cetyl alcohol, and tyloxapol) Powder for SuspensionGlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709-3398
NDA 20-087Floxin (ofloxacin) Solution for InjectionOrtho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Pharmaceutical Research & Development, LLC
NDA 20-137Demadex (torsemide) InjectionHoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199
NDA 20-144Transderm-Nitro (nitroglycerin)Novartis Pharmaceuticals Corp.
NDA 20-154Videx (didanosine) Chewable TabletsBristol-Meyers Squibb, 5 Research Pkwy., Signature 91 Bldg., Wallingford, CA 06492
NDA 20-155Videx (didanosine) Buffered Powder for Oral SolutionDo.
NDA 20-199Hivid (zalcitabine) TabletsHoffman-La Roche, Inc.
NDA 20-250Halfan (halofantrine HCl) TabletsGlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929
NDA 20-306Fludeoxyglucose F-18 InjectionDownstate Clinical PET Center—Methodist Medical Center of Illinois, 221 NE. Glen Oak Ave., Peoria, IL 61636-0002
NDA 20-443Geref (sermorelin acetate) for InjectionEMD Serono, Inc.
NDA 20-545Procanbid (procainamide HCl) Extended-Release Tablets, 500 mg and 1,000 mgKing Pharmaceuticals, Inc.
NDA 20-686LumenHance (manganese chloride tetrahydrate) for SolutionBracco Diagnostics Inc., 107 College Rd. East, Princeton, NJ 08540
NDA 20-773SonoRX (simethicone coated cellulose) SuspensionDo.
NDA 20-791Testoderm TTS (testosterone transdermal system), 5 mg/24 hAlza Corp.
NDA 21-019Compazine (prochlorperazine maleate) Extended-Release CapsulesGlaxoSmithKline, Collegeville, PA 19426
NDA 21-868Exubera (insulin recombinant human) Inhalation Powder, 1 mg and 3 mgPfizer, Inc.
ANDA 40-092Digoxin Injection USP, 0.1 mg/mLHospira, Inc.
NDA 50-109Mithracin (plicamycin) Injection, 2.5 mgPfizer, Inc.
NDA 50-286Terramycin (oxytetracycline HCl) CapsulesDo.
NDA 50-316Lincocin (lincomycin HCl) Capsules, 250 mg and 500 mgPharmacia & Upjohn Co., c/o Pfizer, Inc.
NDA 50-461Ancef (cefazolin) for InjectionSmithKline Beecham, d/b/a GlaxoSmithKline, Philadelphia, PA 19101-7929
NDA 50-529Pediazole (erythromycin ethylsuccinate and sulfisoxazole acetyl) for Oral SuspensionRoss Products Division, Abbott Laboratories, 3300 Stelzer Rd., Columbus, OH 43219-3034
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NDA 50-613Cefobid (cefoperazone sodium) InjectionPfizer, Inc.
NDA 50-667Lorabid (loracarbef for oral suspension USP), 100 mg/5 mL and 200 mg/5 mLKing Pharmaceuticals, Inc.
NDA 50-763Mitozytrex (mitomycin) for Injection, 5 mg/vialSuperGen, Inc., 4140 Dublin Blvd., suite 200, Dublin, CA 94568
ANDA 61-014Terramycin (oxytetracycline HCl) Ophthalmic SolutionPfizer, Inc.
ANDA 61-229Polysporin Ophthalmic Ointment (bacitracin zinc and polymyxin B sulfate ophthalmic ointment)Monarch Pharmaceuticals, Inc. (a wholly-owned subsidiary of King Pharmaceuticals, Inc.), 501 5th St., Bristol, TN 37620
ANDA 64-099Amikacin Sulfate Injection USP, 250 mg/mLHospira, Inc.
ANDA 70-252Naloxone HCl Injection USP, 0.02 mg/mLDo.
ANDA 70-253Naloxone HCl Injection USP, 0.02 mg/mLDo.
ANDA 71-166Bupivacaine HCl and Epinephrine Injection USPDo.
ANDA 71-169Bupivacaine HCl and Epinephrine Injection USPDo.
ANDA 71-171Bupivacaine HCl and Epinephrine Injection USPDo.
ANDA 73-685Acilac (lactulose solution USP), 10 grams (g)/15 mLNostrum Laboratories, Inc., 1800 North Topping Ave., Kansas City, MO 64120
ANDA 73-686Laxilose (lactulose solution USP), 10 g/15 mLDo.
ANDA 74-083Nitroglycerin in 5% Dextrose Injection, 0.1 mg/mLHospira, Inc.
ANDA 74-127Atenolol Tablets USP, 50 mg and 100 mgNostrum Laboratories, Inc.
ANDA 74-337Furosemide Injection USP, 10 mg/mLHospira, Inc.
ANDA 74-391Diclofenac Sodium Delayed-Release Tablets USP, 25 mg, 50 mg, and 75 mgRoxane Laboratories, Inc., 1809 Wilson Rd., P.O. Box 16532, Columbus, OH 43216-6532
ANDA 74-403Dopamine HCl Injection USP, 40 mg/mLHospira, Inc.
ANDA 74-404Atenolol and Chlorthalidone Tablets USP, 50 mg/25 mg and 100 mg/25 mgNostrum Laboratories, Inc.
ANDA 74-474Pindolol Tablets USP, 5 mg and 10 mgDo.
ANDA 74-740Atracurium Besylate Injection USP, 10 mg/mLHospira, Inc.
ANDA 74-741Atracurium Besylate Injection USP, 10 mg/mLDo.
ANDA 75-088Cromoptic (cromolyn sodium) Ophthalmic Solution, 4%King Pharmaceuticals, Inc.
ANDA 75-162Clozapine Tablets USP, 25 mg and 100 mgPar Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977
ANDA 75-466Doxazosin Mesylate Tablets, 1 mg, 2 mg, 4 mg, and 8 mgGenpharm Inc., c/o Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504-4310
ANDA 75-558Vecuronium Bromide for Injection, 4 mg/AmpulHospira, Inc.
ANDA 75-762Ofloxacin Injection, 40 mg/mLBedford Laboratories, Division of Ben Venue Laboratories, Inc., 300 Northfield Rd., Bedford, OH 44146
ANDA 75-899Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mgSynthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709
ANDA 76-138Ciprofloxacin HCl Tablets USP, 250 mg, 500 mg, and 750 mgNostrum Laboratories, Inc.
ANDA 76-213Fluconazole Tablets, 50 mg, 100 mg, 150 mg, and 200 mgRoxane Laboratories, Inc.
ANDA 76-270Mirtazapine Tablets USP, 15 mg, 30 mg, and 45 mgDo.
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ANDA 76-476Benazepril HCl Tablets, 5 mg, 10 mg, 20 mg, and 40 mgMylan Pharmaceuticals, Inc.
ANDA 76-489Anagrelide HCl Capsules, 0.5 mg and 1 mgRoxane Laboratories, Inc.
ANDA 77-249Oxandrolone Tablets USP, 2.5 mg and 10 mgDo.
ANDA 77-445Polyethylene Glycol 3350 Powder for Oral SolutionTeva Pharmaceuticals USA, 1090 Horsham Rd., P.O. Box 1090, North Wales, PA 19454
ANDA 77-648Zonisamide Capsules, 25 mg, 50 mg, and 100 mgRoxane Laboratories, Inc.
ANDA 78-026Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg, and 40 mgDo.
ANDA 81-008Strifon Forte DSC (chlorzoxazone tablets USP), 500 mgFerndale Laboratories, 780 West 8th Mile Rd., Ferndale, MI 48220
ANDA 81-095Acetaminophen, Aspirin, and Codeine Phosphate Capsules, 150 mg/180 mg/15 mgMikart, Inc., 1750 Chattahoochee Ave., Atlanta, GA 30318
ANDA 83-283Isoproterenol HCl Injection USP, 0.02 mg/mLHospira, Inc.
ANDA 83-838Promethazine HCl Injection USPDo.
ANDA 84-074Bethanechol Chloride Tablets USP, 25 mgLannett Co., Inc., 9000 State Rd., Philadelphia, PA 19136
ANDA 84-702Bethanechol Chloride Tablets USP, 5 mgDo.
ANDA 84-712Bethanechol Chloride Tablets USP, 10 mgDo.
ANDA 84-735Apresazide (hydralazine HCl and hydrochlorothiazide) Capsules, 25 mg/25 mgNovartis Pharmaceuticals Corp.
ANDA 84-810Apresazide (hydralazine HCl and hydrochlorothiazide) Capsules, 50 mg/50 mgDo.
ANDA 86-366Acetaminophen and Codeine Phosphate Oral Solution USP, 120 mg/12 mg per 5 mLRoxane Laboratories, Inc.
ANDA 87-563Quibron-T/SR (theophylline) Extended-Release Tablets, 300 mgMonarch Pharmaceuticals, Inc.
ANDA 88-126Aminophylline Oral Solution USP, 105 mg/5 mLRoxane Laboratories, Inc.
ANDA 88-656Quibron-T (theophylline) Tablets, 300 mgMonarch Pharmaceuticals, Inc.
ANDA 89-650Lidocaine HCl and Epinephrine Injection USPHospira, Inc.

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 18, 2009.

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Dated: April 30, 2009.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. E9-11628 Filed 5-18-09; 8:45 am]