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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N-0159]

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

June 4, 2004

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 5-292

Estinyl (ethinyl estradiol) Tablets

Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033

NDA 5-795

Furacin (nitrofurazone)

Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850

NDA 6-110

Dienestrol (dienestrol) Cream

Ortho-McNeil Pharmaceutical, Inc., c/o Johnson & Johnson Research & Development, L.L.C., 920 Highway 202, P.O. Box 300, Raritan, NJ 08869#ndash;0602

NDA 6-800

Paradione (paramethadione)

Abbott Laboratories, D-491/AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157

NDA 7-110

Cortone Acetate (cortisone acetate injectable suspension USP) Injectable Suspension

Merck & Co., Inc., Sumneytown Pike,

BLA-20, P.O. Box 4, West Point, PA 19486

NDA 7-707

Phenurone (phenacemide) Tablets

Abbott Laboratories

NDA 7-750

Cortone Acetate (cortisone acetate tablet USP) Tablets

Merck & Co., Inc.

NDA 8-328

Spectrocin

Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000

NDA 8-604

Phenergan VC Syrup (promethazine hydrochloride (HCl) and phenylephrine HCl) and Phenergan Expectorant (promethazine HCl, ipecac, and potassium guaiacolsulfonate)

Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299

NDA 8-857

Phenergan Injection (promethazine HCl)

Do.

NDA 9-298

Amm-I-Dent (sodium lauroyl sarcosinate/urea/ammonium phosphate) Toothpaste and Tooth Powder

Block Drug Co., Inc., 257 Cornelison Ave., Jersey City, NJ 07302

NDA 10-039

Avlosulfon (dapsone) Tablets

Wyeth Pharmaceuticals

NDA 10-727

Peri-Colace Capsules (30 milligrams (mg) casanthranol/100 mg docusate sodium) and Syrup (30 mg casanthranol/60 mg docusate sodium per 15 milliliters (mL))

Shire Pharmaceutical Development, Inc.

NDA 10-775

Trilafon (perphenazine) Tablets

Schering Corp.

NDA 10-858

Enzactin (triacetin) Cream

Wyeth Consumer Healthcare, Five Giralda Farms, Madison, NJ 07940-0871

NDA 10-971

PMB (conjugated estrogens USP with meprobamate) Tablets

Wyeth Pharmaceuticals

NDA 11-140

Enzactin (triacetin) Powder

Wyeth Consumer Healthcare

NDA 11-460

Lanesta (chlorindanol) Vaginal Gel

Sanofi-Synphelabo, Inc., 90 Park Ave., New York, NY 10016

NDA 11-860

Humorsol (demecarium bromide) Ophthalmic Solution

Merck & Co., Inc.

NDA 11-977

Decadron Ophthalmic Ointment (dexamethasone sodium phosphate ophthalmic ointment)

Do.

NDA 12-052

Hydrocortone (hydrocortisone sodium phosphate injection USP) Injection, 50 mg/mL

Do.

NDA 12-071

Decadron (dexamethasone sodium phosphate injection USP) Injection, 4 mg/mL and 24 mg/mL

Do.

NDA 12-095

Orinase (sterile tolbutamide sodium) Diagnostic Sterile Powder for Injection

Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199

NDA 12-283

Hygroton (chlorthalidone) Tablets, 25 mg, 50 mg, and 100 mg

Aventis Pharmaceuticals, Inc., Mail Stop BX2 - 209G, 200 Crossing Blvd., Bridgewater, NJ 08807-0890

NDA 12-359

Salutensin and Salutensin-DEMI (hydroflumethiazide and reserpine) Tablets

Shire Laboratories, Inc., c/o Shire Pharmaceutical Development, Inc., 1801 Research Blvd., suite 600, Rockville, MD 20850

NDA 12-376

Decadron (dexamethasone) Elixir, 0.5 mg/5 mL

Merck & Co. Inc.

NDA 12-594

Metahydrin (trichlormethiazide) Tablets, 2 mg and 4 mg

Aventis Pharmaceuticals, Inc.

NDA 12-657

Celestone (betamethasone tablets USP) Tablets

Schering Corp.

NDA 12-972

Metatensin (trichlormethiazide and reserpine) Tablets, 2 mg/0.1 mg and 4 mg/0.1 mg

Aventis Pharmaceuticals, Inc.

NDA 14-116

Johnson #Johnson First Aid Spray (dequainium acetate and cetylpyridinium chloride)

Johnson & Johnson Consumer Products Co., 199 Grandview Rd., Sillman, NJ 08558

NDA 14-122

Protopam (pralidoxime chloride) Tablets

Wyeth Pharmaceuticals

NDA 14-127

Xylocaine (lidocaine) 5% Solution

AstraZeneca LP, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355

NDA 14-713

Etrafon (perphenazine and amitriptyline HCl) and Etrafon Forte Tablets

Schering Corp.

NDA 15-103

Regroton (chlorthalidone, 50 mg and reserpine, 0.25 mg) and Demi-Regroton (chlorthalidone, 25 mg and reserpine, 0.125 mg) Tablets

Aventis Pharmaceuticals, Inc.

NDA 16-034

Vontrol (diphenidol HCl) Injection

GlaxoSmithKline, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101-7929

NDA 16-035

Vontrol (diphenidol pamoate) Suspension

Do.

NDA 16-036

Vontrol (diphenidol) Suppositories

Do.

NDA 16-087

Valium (diazepam) Injection

Roche Laboratories, Inc., 340 Kingsland St., Nutley, NJ 07110-1199

NDA 16-110

Prolixin (fluphenazine enanthate) Injection, 25 mg/mL

Apothecon, c/o Bristol-Myers Co., P.O. Box 4500, Princeton, NJ 08543-4500

NDA 16-618

Pondimin (fenfluramine HCl) Tablets and Ponderex (fenfluramine HCl) Capsules

A.H. Robins Co., c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299

NDA 16-647

Quinaglute (quinidine gluconate) Dura-Tabs

Berlex Laboratories, Inc., 340 Changebridge Rd., P.O. Box 1000, Montville, NJ 07045-1000

NDA 16-786

Ovral 28 (norgestrel/ethinyl estradiol) and Ferrous Fumarate Tablets

Wyeth Pharmaceuticals

NDA 16-803

Bronkaid (epinephrine inhalation aerosol) Mist

Bayer Consumer Care Division, 36 Columbia Rd., P.O. Box 1910, Morristown, NJ 07962-1910

NDA 16-849

Selsun Blue Shampoo

Ross Laboratories, 625 Cleveland Ave., Columbus, OH 43215-1754

NDA 16-883

Antiminth (pyrantel pamoate) Oral Suspension

Pfizer Consumer Healthcare, 201 Tabor Rd., Morris Plains, NJ 07950

NDA 16-912

Larodopa (levadopa) Tablets and Capsules

Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199

NDA 16-985

Gleem (sodium fluoride) Dentrifice

Proctor & Gamble Pharmaceuticals, Inc., Oral Care Products Division, 8700 Mason-Montgomery Rd., Mason, OH 45040

NDA 17-020

Panwarfin (warfarin sodium tablets USP) Tablets, 2 mg, 2.5 mg, 5 mg, 7.5 mg, 10 mg, and 25 mg

Abbott Laboratories

NDA 17-389

Dial 2 (pyrithione zinc) Dandruff Shampoo

Armour-Dial, Inc., 15101 N. Scottsdale Rd., Scottsdale, AZ 85260

NDA 17-535

Lorelco (probucol) Tablets

Aventis Pharmaceuticals, Inc.

NDA 17-536

Diprosone (betamethasone dipropionate) Cream, 0.05%

Schering Corp.

NDA 17-684

Pyrolite (technetium Tc-99m pyro- and trimeta-phosphates kit)

CIS-US, Inc., 10 De Angelo Dr., Bedford, MA 01730

NDA 17-710

Nalfon (fenoprofen calcium) Tablets

Dista Products Ltd., c/o Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285

NDA 17-736

Paxipam (halazepam) Tablets, 20 mg and 40 mg

Schering Corp.

NDA 17-853

Proventil (albuterol sulfate) Tablets, 2 mg and 4 mg

Do.

NDA 17-895

Janimine (imipramine HCl) Tablets

Abbott Laboratories

NDA 17-952

Trimpex (trimethoprim) Tablets

Hoffman-La Roche, Inc.

NDA 18-306

NasalCrom (cromolyn sodium) Nasal Solution

Pharmacia Consumer Healthcare, 100 Route 206 North, Peapack, NJ 07977

NDA 18-521

Vancenase (beclomethasone dipropionate) Nasal Inhaler

Schering Corp.

NDA 18-584

Beconase (beclomethasone dipropionate) Inhalation Aerosol

GlaxoSmithKline, P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709

NDA 18-587

Wytensin (guanabenz acetate) Tablets, 4 mg, 8 mg, and 16 mg

Wyeth Pharmaceuticals

NDA 18-592

Monistat 5 (miconazole nitrate) Tampons, 100 mg

Personal Products Co., 199 Grandview Rd., Skillman, NJ 08558

NDA 19-059

Inderide LA (propranolol HCl and hydrochlorothiazide) Capsules, 80 mg/50 mg, 120 mg/50 mg, and 160 mg/50 mg

Ayerst Pharmaceuticals, c/o Wyeth Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101-8299

NDA 19-279

Dimetane DX (brompheniramine maleate/ pseudoephedrine HCl/dextromethorphan HBr) Cough Syrup

A.H. Robins Co., c/o Wyeth Pharmaceuticals

NDA 19-428

Pseudoephedrine HCl and Chlorpheniramine Maleate Extended-Release Capsules

Central Pharmaceuticals, c/o Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201

NDA 19-757

Chibroxin (norfloxacin) Sterile Ophthalmic Solution, 0.3%

Merck &Co., Inc.

NDA 19-858

Cipro (ciprofloxacin) in Sodium Chloride

Bayer Corp.

NDA 20-055

Glyburide (micronized) Tablets

Aventis Pharmaceuticals, Inc.

NDA 20-058

Thioplex (thiotepa) For Injection)

Immunex Corp., 51 University St., Seattle, WA 98101-2936

NDA 20-135

Motrin (ibuprofen) Chewable Tablets

McNeil Consumer & Specialty Pharmaceuticals, 7050 Camp Hill Rd., Fort Washington, PA 19034-2299

NDA 20-233

Rhinocort (budesomide) Nasal Inhaler

AstraZeneca LP

NDA 20-240

Renormax (spirapril HCl) Tablets, 3 mg, 6 mg, 12 mg, and 24 mg

Schering Corp.

NDA 20-418

Motrin (ibuprofen) Caplets

McNeil Consumer & Specialty Pharmaceuticals

NDA 20-469

Vancenase AQ (beclomethasone dipropionate monohydrate) Nasal Spray

Schering Corp.

NDA 20-476

Motrin (ibuprofen) Oral Drops

McNeil Consumer &Specialty Pharmaceuticals

NDA 20-874

Lunelle (estradiol cypionate and medroxyprogesterone acetate) Injection

Pharmacia Corp., c/o Pfizer Pharmaceuticals Group, 235 E. 42d St., New York, NY 10017-5755

NDA 20-951

Tagamet HB (cimetidine) Suspension

GlaxoSmithKline Consumer Healthcare LP, 1500 Littleton Rd., Parsippany, NJ 07054-3884

NDA 50-012

Garamycin (gentamicin sulfate injection USP) Injectable

Schering Corp.

NDA 50-051

Grisactin (griseofulvin, microcrystalline) Capsules

Wyeth Pharmaceuticals

NDA 50-092

Pathocil (dicloxacillin sodium) for Suspension

Do.

NDA 50-094

Erythrocin (erythromycin) Suppositories

Abbott Laboratories

NDA 50-111

Unipen (nafcillin sodium) Capsules

Wyeth Pharmaceuticals

NDA 50-262

Declomycin (demeclocycline HCl) Capsules

Lederle Laboratories, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299

NDA 50-273

Achromycin (tetracycline HCl) Intravenous Injection

Do.

NDA 50-276

Achromycin (tetracyclilne HCl and procaine HCl) Sterile Intramuscular Injection

Do.

NDA 50-296

Erythrocin Suspension

Abbott Laboratories

NDA 50-324

Neodecadron (neomycin sulfate and dexamethasone sodium phosphate) Ophthalmic Ointment

Merck Research Laboratories, Sumneytown Pike, P.O. Box 4, BLA-20, West Point, PA 19486-0004

NDA 50-341

Fungizone (amphotericin B) Oral Suspension

Bristol-Myers Squibb Co.

NDA 50-425

Garamycin (gentamicin sulfate) Ophthalmic Ointment

Schering Corp.

NDA 50-439

Erythrocin (erythromycin stearate)

Abbott Laboratories

NDA 50-482

Keflin (cephalothin sodium) for Injection

Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285

NDA 50-744

Periostat (doxycycline hyclate USP) Capsules, 20 mg

CollaGenex Pharmaceuticals, Inc., 301 South State St., Newtown, PA 18940

ANDA 60-006

Pen-Vee K (penicillin V potassium) Tablets, 125 mg, 250 mg, and 500 mg (base)

Wyeth Pharmaceuticals

ANDA 60-611

Neomycin Sulfate and Methylprednisolone Acetate Topical Cream

Pharmacia & Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001

ANDA 60-624

Omnipen (ampicillin) Capsules, 250 mg and 500 mg

Wyeth Pharmaceuticals

ANDA 62-178

Grisactin Ultra (griseofulvin, ultramicro crystalline) Tablets, 125 mg and 250 mg

Do.

ANDA 62-438

Grisactin Ultra (griseofulvin, ultramicro crystalline) Tablets, 165 mg and 330 mg

Do.

ANDA 62-549

Keflin (cephalothin sodium for injection USP), 1 g and 2 g

Lilly Research Laboratories

ANDA 62-690

Ticar (ticarcillin disodium) Injection, 3 g

GlaxoSmithKline

ANDA 62-905

Clindamycin Phosphate Injection USP, 150 mg/mL

Loch Pharmaceuticals, c/o Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146

ANDA 63-087

Lincomycin HCl USP

Abbott Laboratories

ANDA 63-321

Vancoled (vancomycin HCl for oral solution USP)

Lederle Laboratories, c/o Wyeth Pharmaceuticals

ANDA 70-188

Naloxone HCl Injection USP, 0.02 mg/mL

Wyeth Pharmaceuticals

ANDA 70-189

Naloxone HCl Injection USP, 0.02 mg/mL

Do.

ANDA 70-190

Naloxone HCl Injection USP, 0.4 mg/mL

Do.

ANDA 70-191

Naloxone HCl Injection USP, 0.4 mg/mL

Do.

ANDA 70-480

Leucovorin Calcium for Injection, 50 mg

Elkins Sinn, c/o Wyeth Pharmaceuticals, P.O. Box 8299, Philadelphia, PA 19101-8299

ANDA 70-917

Nalbuphine HCl Injection, 20 mg/mL

Abbott Laboratories

ANDA 72-639

Metoclopramide HCl Tablets USP, 10 mg

Clonmel Healthcare Ltd., c/o STADA Pharmaceuticals Inc., U.S. Agent, 5 Cedar Brook Dr., Cranbury, NJ 08512

ANDA 74-051

Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and 120 mg

Apothecon, c/o Bristol-Myers Squibb Co., P.O. Box 4500, Princeton, NJ 08543-4500

ANDA 74-211

Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg

Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216

ANDA 74-257

Naproxen Sodium Tablets USP

Do.

ANDA 80-454

Meperidine HCl Tablets USP, 50 mg

Do.

ANDA 80-553

Thiamine HCl Injection USP, 100 mg/mL

Do.

ANDA 80-554

Cyanocobalamin Injection USP

Do.

ANDA 80-577

Diphenhydramine HCl Injection USP, 50 mg/mL

Do.

ANDA 81-224

Leucovorin Calcium for Injection, 100 mg

Elkins Sinn, c/o Wyeth Pharmaceuticals

ANDA 81-239

Cycrin (medroxyprogesterone acetate) Tablets USP, 2.5 mg

Do.

ANDA 81-240

Cycrin (medroxyprogesterone) Tablets USP, 5 mg

Do.

ANDA 83-159

Calcium Gluceptate Injection

Abbott Laboratories

ANDA 83-262

Secobarbital Sodium Injection USP, 50 mg/mL

Wyeth Pharmaceuticals

ANDA 83-640

Quinidine Sulfate Tablets USP, 200 mg

Roxane Laboratories, Inc.

ANDA 84-316

Dimenhydrinate Injection USP, 50 mg

Wyeth Pharmaceuticals

ANDA 84-386

Digoxin Injection USP, 500 micrograms/2 mL

Do.

ANDA 84-445

Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP) No. 3 Capsules

A. H. Robins Co.

ANDA 84-446

Phenaphen with Codeine (acetaminophen and codeine phosphate capsules USP) No. 4 Capsules

Do.

ANDA 85-328

Theo-Dur (theophylline) Extended-Release Tablets, 100 mg and 300 mg

Schering Corp.

ANDA 85-632

Quinidine Sulfate Tablets USP, 300 mg

Roxane Laboratories, Inc.

ANDA 86-134

Nitro-Bid Ointment (nitroglycerin ointment USP, 2%)

Altana Inc., 60 Baylis Rd., Melville, NY 11747

ANDA 86-348

Prochlorperazine Edisylate Injection USP, 5 mg (base)/mL

Wyeth Pharmaceuticals

ANDA 86-998

Theo-Dur (theophylline) Extended-Release Tablets, 200 mg

Schering Corp.

ANDA 88-584

DHCplus (dihydrocodeine bitartrate, acetaminophen, and caffeine) Capsules, 356.4 mg

Purdue Frederick Co., One Stamford Forum, Stamford, CT 06901-3431

ANDA 89-116

Brompheril (dexbrompheniramine maleate/ pseudoephedrine sulfate) Extended-Release Tablets, 6 mg/120 mg

Copley Pharmaceuticals, Inc., c/o Teva Pharmaceuticals, 1090 Horsham Rd., North Wales, PA 19454

ANDA 89-131

Theo-Dur (theophylline) Extended-Release Tablets, 450 mg

Schering Corp.

ANDA 89-386

Cycrin (medroxyprogesterone acetate) Tablets, 10 mg

Wyeth Pharmaceuticals

ANDA 89-573

Methylprednisolone Sodium Succinate for Injection USP, 40 mg

Abbott Laboratories

ANDA 89-574

Methylprednisolone Sodium Succinate for Injection USP, 125 mg

Do.

ANDA 89-575

Methylprednisolone Sodium Succinate for Injection USP, 500 mg

Do.

ANDA 89-576

Methylprednisolone Sodium Succinate for Injection USP, 1000 mg

Do.

ANDA 89-822

Uni-Dur (theophylline) Extended-Release Tablets, 400 mg

Schering Corp.

ANDA 89-823

Uni-Dur (theophylline) Extended-Release Tablets, 600 mg

Do.

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 June 4, 2004.

Dated: March 22, 2004.

Steven K. Galson,

Acting Deputy Director, Center for Drug Evaluation and Research.

[FR Doc. 04-10194 Filed 5-4-04; 8:45 am]

BILLING CODE 4160-01-S