AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 28 new drug applications (NDA's). 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 September 30, 2000.
FOR FURTHER INFORMATION CONTACT:
Olivia A. Pritzlaff, 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.
| Application No. | Drug | Applicant |
|---|---|---|
| NDA 4-038 | Diethylstilbestrol (DES) Injection. | Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 4-039 | DES Tablets. | Do. |
| NDA 4-040 | DES Suppository. | Do. |
| NDA 4-041 | DES Tablets. | Do. |
| NDA 4-056 | Stilbetin Tablets (Diethylstilbestrol Tablets USP). | Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000. |
| NDA 6-327 | Isuprel (Isoproterenol Hydrochloride) Inhalation Solution. | Sanofi-Synthelabo, Inc., 90 Park Ave., New York, NY 10016-1389. |
| NDA 7-371 | Mecostrin Injection (Dimethyl Tubocurarine Chloride). | Bristol-Myers Squibb Co. |
| NDA 8-392 | Nydrazid (Isoniazid USP) Tablets, Syrup, Capsules. | Do. |
| NDA 9-052 | Rezipas (Aminosalicylic Acid Resin Powder). | Do. |
| NDA 9-273 | Rauwolfia Serpentina, 50-milligram (mg) and 100-mg Tablets, 35-mg Capsule. | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| NDA 9-627 | Reserpine, 0.1-mg, 0.25-mg, 0.5-mg, and 1-mg Tablets. | Do. |
| NDA 10-010 | Stilphostrol (Diethylstilbestrol Diphosphate) Injection and Tablets. | Bayer Corp., 400 Morgan Lane, West Haven, CT 06516-4175. |
| NDA 10-347 | Delalutin (Hydroxyprogesterone Caproate Injection USP). | Bristol-Myers Squibb Co. |
| NDA 11-359 | Ora-testryl (Fluoxymesterone Tablets USP). | Do. |
| NDA 11-642 | Cardioquin (Quinidine Polygalacturonate) 275-mg Tablets. | Purdue Frederick Co., 100 Connecticut Ave., Norwalk, CT 06850-3590. |
| NDA 11-745 | Konakion (Phytonadione) Injection. | Hoffman-La Roche, Inc., 340 Kingsland St., Nutley, NJ 07110. |
| NDA 12-248 | Plegine (Phendimetrazine Tartate) Tablets. | Wyeth Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101-8299. |
| NDA 12-339 | Bronkometer (Isoetharine Mesylate Inhalation Aerosol) and Bronkosol (Isoetharine Hydrochloride Inhalation Solution). | Sanofi-Synthelabo, Inc. |
| NDA 16-911 | Delalutin (Hydroxyprogesterone Caproate Injection USP). | Bristol-Myers Squibb Co. |
| NDA 17-424 | Septisol Foam (Hexachlorophene). | Steris Corp., P.O. Box 147, St. Louis, MO 63166-0147. |
| NDA 18-672 | Nitro IV 5 mg/milliliters (mL) Injection and Nitronal Injection. | G. Pohl-Boskamp GmbH & Co., Kieler Strasse 11, D-25551 Hohenlockstedt, Germany. |
| NDA 18-762 | Brethaire (Terbutaline Sulfate) Inhalation Aerosol. | Novartis Pharmaceuticals Corp., 59 Route 10, East Hanover, NJ 07936-1080. |
| NDA 19-069 | Mycelex (Clotrimazole) Vaginal Tablets. | Bayer Corp. |
| NDA 19-082 | Dalgan (Dezocine) Injection, 5, 10, and 15 mg/mL. | AstraZeneca LP, 725 Chesterbrook Blvd., Wayne, PA 19087-5677. |
| NDA 19-174 | Trandate HCT (Labetalol Hydrochloride/Hydrochlorothiazide) Tablets. | Glaxo Wellcome, Inc., P.O. Box 13398, Research Triangle Park, NC 27709. |
| NDA 19-287 | DIZAC (Diazepam Injectable Emulsion). | Pharmacia & Upjohn, 7000 Portage Rd., Kalamazoo, MI 49001-0199. |
| NDA 20-559 | Tritec (Ranitidine Bismuth Citrate) Tablets. | Glaxo Wellcome, Inc. |
| NDA 21-048 | 17 β-Estradiol Transdermal System. | R. W. Johnson Pharmaceutical Research Institute, 920 Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602. |
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 September 30, 2000.
Dated: September 5, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-23477-Filed 9-12-00; 8:45 am]
BILLING CODE 4160-01-F