66 FR 159 pgs. 43017-43019 - Schering Corp. et al.; Withdrawal of Approval of 51 New Drug Applications and 25 Abbreviated New Drug Applications
Type: NOTICEVolume: 66Number: 159Pages: 43017 - 43019
Docket number: [Docket No. 01N-0336]
FR document: [FR Doc. 01-20605 Filed 8-15-01; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01N-0336]
Schering Corp. et al.; Withdrawal of Approval of 51 New Drug Applications and 25 Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is withdrawing approval of 51 new drug applications (NDAs) and 25 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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:
Effective September 17, 2001.
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 3-158 | Oreton Methyl (methyltestosterone) Tablets, 10 milligrams (mg) and 25 mg. | Schering Corp., 2000 Galloping Hill Rd., Kenilworth, NJ 07033. |
| NDA 5-963 | Sodium Sulamyd (sulfacetamide sodium) Ophthalmic Solution and Ointment. | Do. |
| NDA 6-325 | Tubocurarine Chloride Injection. | Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 6-632 | Metubine Iodide (metocurine iodide) Injection. | Do. |
| NDA 6-772 | Vasoxyl (methoxamine hydrochloride (HCl)) Injection. | GlaxoSmithKline (GSK), P.O. Box 13398, Five Moore Dr., Research Triangle Park, NC 27709. |
| NDA 6-925 | Nisentil (alphaprodine HCl) Injection. | Hoffman-LaRoche, Inc., 340 Kingsland St., Nutley, NJ 07110-1199. |
| NDA 7-600 | Surital (thiamylal sodium). | Parkdale Pharmaceuticals, 2800 Plymouth Rd., Ann Arbor, MI 48105. |
| NDA 8-200 | Sodium Iodide I-131 Capsules, Solution, and Injection. | Syncor International Corp., 6464 Canoga Ave., Woodland Hills, CA 91367. |
| NDA 8-592 | Ravocaine HCl (propoxycaine HCl and procaine HCl, with nordefrin or norepinephrine bitartrate). | Eastman Kodak Co., Health Imaging, 343 State St., Rochester, NY 14612-1122. |
| NDA 9-127 | Cortril (hydrocortisone) Tablets. | Pfizer, Inc., 235 East 42d St., New York, NY 10017. |
| NDA 9-130 | Cortril (hydrocortisone acetate) Ophthalmic Ointment. | Do. |
| NDA 9-238 | Progesterone Injection. | Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285. |
| NDA 9-458 | Cortisone Acetate Tablets, 25 mg. | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| NDA 9-996 | Sterane (prednisolone) Tablets. | Pfizer, Inc. |
| NDA 10-423 | Lorfan (levallorphan tartrate) Injection. | Hoffman-LaRoche, Inc. |
| NDA 10-554 | Magnacort (hydrocortamate HCl) Topical Ointment. | Pfizer Pharmaceuticals, 235 East 42d St., New York, NY 10017. |
| NDA 11-539 | Ultra-Feminine (Topical Liquid). | Coscelebre, Inc., 415 Madison Ave., New York, NY 10017. |
| NDA 11-557 | Trilafon (perphenazine) Concentrate, 16 mg/5 mL (milliliters). | Schering Corp. |
| NDA 11-679 | Pentothal Sodium (thiopental sodium) Suspension. | Abbott Laboratories, D-389, Bldg. AP30, 200 Abbott Park Rd., Abbott Park, IL 60064-6157. |
| NDA 12-148 | Oreticyl Tablets and Oreticyle Forte (hydrochlorothiazide and deserpidine) Tablets. | Do. |
| NDA 12-715 | Gantanol (sulfamethoxazole) Tablets. | Hoffman-LaRoche, Inc. |
| NDA 13-056 | Penthrane (methoxyflurane) Inhalation Liquid. | Abbott Laboratories. |
| NDA 13-934 | Stoxil (idoxuridine) Ophthalmic Solution, 0.1%. | SmithKline Beecham Pharmaceuticals, One Franklin Plaza, P.O. Box 7929, Philadelphia, PA 19101. |
| NDA 14-083 | Apodol (anileridine HCl) Tablets. | Bristol-Myers Squibb, P.O. Box 4000, Princeton, NJ 08543-4000. |
| NDA 14-087 | Apodol (anileridine) Injection. | Do. |
| NDA 15-868 | Stoxil (idoxuridine) Ophthalmic Ointment, 0.5%. | SmithKline Beecham Pharmaceuticals. |
| NDA 17-255 | DTPA (chelate) Multidose (kit for the preparation of Tc-99m pentetate injection). | Nycomed Amersham Imaging, 101 Carnegie Center, Princeton, NJ 08540. |
| NDA 17-256 | Xenon Xe-133. | Do. |
| NDA 17-257 | Selenomethionine Se-75 Injection. | Do. |
| NDA 17-266 | Technetium Tc-99m Sulfur Colloid Injection. | Do. |
| NDA 17-267 | Sodium Pertechnetate Tc-99m Injection. | Do. |
| NDA 17-383 | Methosarb (calusterone) Tablets. | The Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001. |
| NDA 17-456 | Technetium Tc-99m Sulfur Colloid. | Do. |
| NDA 17-483 | Methadone HCl Bulk (methadone HCl). | Penick Corp., 158 Mount Olivet Ave., Newark, NJ 07114. |
| NDA 17-562 | Technetium Tc-99m Diphosphonate Injection (Tin Kit). | Nycomed Amersham Imaging. |
| NDA 17-664 | Sodium Polyphosphate Injection (Tin Kit). | Do. |
| NDA 17-667 | Stannous Diphosphonate Injection. | Do. |
| NDA 18-228 | Hypnomidate (etomidate) Injection. | Janssen Research Foundation, 1125 Trenton-Harbourton Rd., P.O. Box 200, Titusville, NJ 08560. |
| NDA 18-289 | Iodohippurate Sodium I-123. | Nycomed Amersham Imaging. |
| NDA 18-871 | Protostat (metronidazole) Tablets. | R. W. Johnson Pharmaceutical Research Institute, Route 202 South, P.O. Box 300, Raritan, NJ 08869-0602. |
| NDA 19-450 | Velosulin BR Human (semisynthetic purified human insulin) Injection. | Novo Nordisk Pharmaceuticals, Inc., 100 College Rd. West, Princeton, NJ 08540. |
| NDA 20-420 | GenESA (arbutamine HCl) Injection. | Gensia Automedics, Inc., 9360 Towne Centre Dr., San Diego, CA 92121. |
| NDA 20-689 | Posicor (miobefradil dihydrochloride) Oral Tablets, 50 mg and 100 mg. | Hoffmann-LaRoche, Inc. |
| ANDA 40-059 | Fluocinolone Acetonide Topical Solution USP, 0.01%. | Bausch Lomb Pharmaceuticals, Inc., 8500 Hidden River Pkwy., Tampa, FL 33637. |
| NDA 50-311 | Rondomycin (methacycline HCl) Capsules. | Pfizer, Inc. |
| NDA 50-448 | Grifulvin (griseofulvin) Oral Suspension. | Johnson Johnson Consumer Products Co., 199 Grandview Rd., Skillman, NJ 8558-9418. |
| NDA 50-637 | Zefazone (cefmetazole sodium) Sterile Powder. | Pharmacia Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001. |
| NDA 50-683 | Zefazone (cefmetazole sodium) Intraveous Solution. | Do. |
| ANDA 60-760 | Oxytetracycline HCl Capsules, 250 mg. | Impax Laboratories, Inc. |
| ANDA 62-223 | Totacillin (Ampicillin Trihydrate for Oral Suspension USP). | SmithKline Beecham Pharmaceuticals. |
| ANDA 62-736 | Bactocill (oxacillin sodium) Injection. | GlaxoSmithKline (GSK). |
| ANDA 64-055 | Neomycin Sulfate and Dexamethosone Sodium Phosphate Ophthalmic Solution | Bausch Lomb Pharmaceuticals, Inc. |
| ANDA 74-813 | Etoposide Injection 20 mg/mL. | Pierre Fabre Medicament, c/o Guidelines Integrated Service, 10320 USA Today Way, Miramar, FL 33062. |
| ANDA 80-079 | Trisulfapyrimidines Tablets USP. | Impax Laboratories, Inc. |
| ANDA 80-151 | Thyroglobulin Tablets USP. | Do. |
| ANDA 80-153 | Isoniazid Tablets USP. | Do. |
| ANDA 80-281 | Oreton Methyl Buccal Tablets (Methyltestosterone Tablets USP). | Schering Corp. |
| ANDA 80-780 | Prednisolone Tablets USP, 5 mg. | Impax Laboratories, Inc. |
| ANDA 80-807 | Diphenhydramine HCl Capsules USP, 25 mg and 50 mg. | Do. |
| ANDA 80-951 | Ergocalciferol Capsules USP. | Do. |
| ANDA 80-952 | Vitamin A Capsules USP. | Do. |
| ANDA 80-953 | Vitamin A Capsules USP. | Do. |
| ANDA 80-955 | Vitamin A Capsules USP. | Do. |
| ANDA 83-011 | Hydrocortisone Cream USP, 1%. | Solvay Pharmaceuticals, Inc., 901 Sawyer Rd., Marietta, GA 30062. |
| ANDA 83-347 | Quinidine Sulfate Tablets USP, 200 mg. | Impax Laboratories, Inc. |
| ANDA 84-214 | Promethazine HCl Tablets USP, 25 mg. | Do. |
| ANDA 84-340 | Triamcinolone Tablets USP, 4 mg. | Do. |
| ANDA 84-575 | Aminophylline Tablets USP, 200 mg. | Do. |
| ANDA 84-577 | Aminophylline Tablets USP, 100 mg. | Do. |
| ANDA 85-098 | Hydrocholorothiazide Tablets USP, 100 mg. | Do. |
| ANDA 85-563 | Glycopyrrolate Tablets, 2 mg. | Circa, 130 Lincoln St., Copiague, NY 11726. |
| ANDA 86-639 | Levsin PB (hyoscyamine sulfate and phenobarbital) Oral Solution. | Schwarz Pharma, Inc., P.O. Box 2038, Milwaukee, WI 53201. |
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 17, 2001.
Dated: August 1, 2001.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 01-20605 Filed 8-15-01; 8:45 am]
BILLING CODE 4160-01-S