E9-11628. Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 92 New Drug Applications and 49 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

Dates:

Effective: June 18, 2009.

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

Dated: April 30, 2009.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.