02-10425. Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of 38 New Drug Applications

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of 38 new drug applications (NDAs). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 May 29, 2002.

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 request, waived their opportunity for a hearing.

NDA No.	Drug	Applicant
740	Ovocyclin Dipropionate Injection and Di-Ovocyclin (Estradiol Dipropionate NF).	Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936.
3-034	Bismakaolin.	The Vale Chemical Co., Inc., 1201 Liberty St., Allentown, PA 18102.
3-353	Tocopherex (Vitamin E) Capsules.	E. R. Squibb & Sons, One Squibb Dr., P.O. Box 191, New Brunswick, NJ 08903-0191.
3-697	Comin Vitamin Capsules.	Forest Pharmaceuticals, Inc., 150 East 58th St., New York, NY 10155-0015.
3-934	Avitol (Vitamin A) Capsules.	Do.
3-962	Sodium Pentobarbital Injection.	Lakeside Laboratories, Milwaukee, WI 53201.
3-993	Beminal Tablets.	Whitehall Laboratories, 685 Third Ave., New York, NY 10017-4076.
4-016	Tonajuve Liquid.	Merrell-National Laboratories, Cincinnati, OH 45215.
5-070	Privine (Naphazoline Hydrochloride USP).	Novartis Pharmaceuticals Corp.
7-012	Vi-Twel (Cyanocobalamin Injection USP).	Berlex Laboratories, Inc., 300 Fairfield Rd., Wayne, NJ 07470-7358.
8-070	Elkosin (sulfisomidine) Tablets and Suspension.	CIBA-GEIGY Corp.
8-418	Pyribenzamine (Tripelennamine Hydrochloride USP) with Zirconium.	Novartis Pharmaceuticals Corp.
8-729	Dorsacaine Ophthalmic Solution.	Sandoz Research Institute, Route 10, East Hanover, NJ 07936.
8-908	InfraRUB Cream.	Whitehall Laboratories
11-073	Wampocaps (niacin) Capsules.	Wallace Laboratories, Cranbury, NJ 08512.
11-123	Vesprin (triflupromazine hydrochloride).	Apothecon, P.O. Box 4500, Princeton, NJ 08543-4500.
11-419	Sterisol Mouthwash and Gargle.	Warner-Lambert Co., 170 Tabor Rd., Morris Plains, NJ 07950.
12-542	Oxalid (oxyphenbutazone) Tablets.	Novartis Pharmaceuticals Corp.
13-273	Nitrofurantoin Tablets.	Albran, Inc., 68-43 Juno St., Forest Hills, NY 11375.
16-000	Sulla (sulfameter) Tablets	Berlex Laboratories, Inc.
17-071	Benzedrine (amphetamine sulfate) Spansule Capsules.	Smith Kline & French Laboratories, 1500 Spring Garden St., P.O. Box 7929, Philadelphia, PA 19101.
17-098	Selenomethionine Se-75 Injection.	Mallinckrodt, Inc., 675 McDonnell Blvd., P.O. Box 5840, St. Louis, MO 63134.
17-109	Prednisone Tablets USP, 20 milligrams (mg).	Roxane Laboratories, Inc., P.O. 16532, Columbus, OH 43216-6532.
17-282	Technetium Tc-99m Sulfur Colloid Kit.	E. I. duPont de Nemours & Co., Inc., 331 Treble Cove Rd., North Billerica, MA 01862.
17-454	Osteoscan (Technetium Tc-99m Etidronate Kit).	Mallinckrodt, Inc.
17-518	Ytterbium Yb-169 DTPA.	3M Health Care Group, 3M Center, St. Paul, MN 55144-1000.
17-678	Technetium Tc-99m Pyrophosphate Kit.	Syncor International Corp., 12847 Arroyo St., Sylmar, CA 91342.
17-704	Dantrium Oral Suspension.	Norwich Easton Pharmaceuticals, Inc., P.O. Box 191, Norwick, NY 13815-00191.
18-102	Medrol (methylprednisolone acetate) Enpak Kit.	The Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199.
18-121	Catarase Ophthalmic Solution.	Novartis Pharmaceuticals Corp.
18-236	ZOMAX (zomepirac sodium) Tablets.	The R. W. Johnson Pharmaceutical Research Institute, Welsh and McKean Rds., Spring House, PA 19477-0776.
18-297	Allopurinol Tablets USP, 100 and 300 mg.	Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 60064.
19-421	Exidine Solution.	Xttrium Laboratories, Inc., 415 West Pershing Rd., Chicago, IL 60609.
50-043	Keflin (cephalothin sodium) Injection.	Lilly Research Laboratories, Lilly Corprate Center, Indianapolis, IN 46285.
50-219	Kafocin.	Do.
50-469	Keflin, Frozen Neutral.	Do.
50-501	Velosef Injection.	Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-6837.
50-540	Mandol Injection.	Lilly Research Laboratories.

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 (21 CFR 5.82), approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective May 29, 2002.

Dated: March 21, 2002.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.