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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 |
|---|---|---|
| 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.
[FR Doc. 02-10425 Filed 4-26-02; 8:45 am]
BILLING CODE 4160-01-S