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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0427]

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

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

BILLING CODE 4160-01-S