E7-21886. Lederle Laboratories et al.; Withdrawal of Approval of 73 New Drug Applications and 62 Abbreviated New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

FOR FURTHER INFORMATION CONTACT:

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

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

Dated: October 26, 2007.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.