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

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Information about this document as published in the Federal Register.

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Food and Drug Administration, HHS.




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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Effective May 29, 2002.

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

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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.DrugApplicant
740Ovocyclin Dipropionate Injection and Di-Ovocyclin (Estradiol Dipropionate NF).Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936.
3-034Bismakaolin.The Vale Chemical Co., Inc., 1201 Liberty St., Allentown, PA 18102.
3-353Tocopherex (Vitamin E) Capsules.E. R. Squibb & Sons, One Squibb Dr., P.O. Box 191, New Brunswick, NJ 08903-0191.
3-697Comin Vitamin Capsules.Forest Pharmaceuticals, Inc., 150 East 58th St., New York, NY 10155-0015.
3-934Avitol (Vitamin A) Capsules.Do.
3-962Sodium Pentobarbital Injection.Lakeside Laboratories, Milwaukee, WI 53201.
3-993Beminal Tablets.Whitehall Laboratories, 685 Third Ave., New York, NY 10017-4076.
4-016Tonajuve Liquid.Merrell-National Laboratories, Cincinnati, OH 45215.
5-070Privine (Naphazoline Hydrochloride USP).Novartis Pharmaceuticals Corp.
7-012Vi-Twel (Cyanocobalamin Injection USP).Berlex Laboratories, Inc., 300 Fairfield Rd., Wayne, NJ 07470-7358.
8-070Elkosin (sulfisomidine) Tablets and Suspension.CIBA-GEIGY Corp.
8-418Pyribenzamine (Tripelennamine Hydrochloride USP) with Zirconium.Novartis Pharmaceuticals Corp.
8-729Dorsacaine Ophthalmic Solution.Sandoz Research Institute, Route 10, East Hanover, NJ 07936.
8-908InfraRUB Cream.Whitehall Laboratories
11-073Wampocaps (niacin) Capsules.Wallace Laboratories, Cranbury, NJ 08512.
11-123Vesprin (triflupromazine hydrochloride).Apothecon, P.O. Box 4500, Princeton, NJ 08543-4500.
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11-419Sterisol Mouthwash and Gargle.Warner-Lambert Co., 170 Tabor Rd., Morris Plains, NJ 07950.
12-542Oxalid (oxyphenbutazone) Tablets.Novartis Pharmaceuticals Corp.
13-273Nitrofurantoin Tablets.Albran, Inc., 68-43 Juno St., Forest Hills, NY 11375.
16-000Sulla (sulfameter) TabletsBerlex Laboratories, Inc.
17-071Benzedrine (amphetamine sulfate) Spansule Capsules.Smith Kline & French Laboratories, 1500 Spring Garden St., P.O. Box 7929, Philadelphia, PA 19101.
17-098Selenomethionine Se-75 Injection.Mallinckrodt, Inc., 675 McDonnell Blvd., P.O. Box 5840, St. Louis, MO 63134.
17-109Prednisone Tablets USP, 20 milligrams (mg).Roxane Laboratories, Inc., P.O. 16532, Columbus, OH 43216-6532.
17-282Technetium Tc-99m Sulfur Colloid Kit.E. I. duPont de Nemours & Co., Inc., 331 Treble Cove Rd., North Billerica, MA 01862.
17-454Osteoscan (Technetium Tc-99m Etidronate Kit).Mallinckrodt, Inc.
17-518Ytterbium Yb-169 DTPA.3M Health Care Group, 3M Center, St. Paul, MN 55144-1000.
17-678Technetium Tc-99m Pyrophosphate Kit.Syncor International Corp., 12847 Arroyo St., Sylmar, CA 91342.
17-704Dantrium Oral Suspension.Norwich Easton Pharmaceuticals, Inc., P.O. Box 191, Norwick, NY 13815-00191.
18-102Medrol (methylprednisolone acetate) Enpak Kit.The Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-0199.
18-121Catarase Ophthalmic Solution.Novartis Pharmaceuticals Corp.
18-236ZOMAX (zomepirac sodium) Tablets.The R. W. Johnson Pharmaceutical Research Institute, Welsh and McKean Rds., Spring House, PA 19477-0776.
18-297Allopurinol Tablets USP, 100 and 300 mg.Abbott Laboratories, 100 Abbott Park Rd., Abbott Park, IL 60064.
19-421Exidine Solution.Xttrium Laboratories, Inc., 415 West Pershing Rd., Chicago, IL 60609.
50-043Keflin (cephalothin sodium) Injection.Lilly Research Laboratories, Lilly Corprate Center, Indianapolis, IN 46285.
50-469Keflin, Frozen Neutral.Do.
50-501Velosef Injection.Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-6837.
50-540Mandol 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.

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Dated: March 21, 2002.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

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[FR Doc. 02-10425 Filed 4-26-02; 8:45 am]