[Federal Register Volume 67, Number 197 (Thursday, October 10, 2002)] [Notices] [Pages 63107-63108] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 02-25882] [[Page 63107]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 02N-0430] Lilly Research Labs et al.; Withdrawal of Approval of 16 New Drug Applications and 30 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 16 new drug applications (NDAs) and 30 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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 November 12, 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 requests, waived their opportunity for a hearing. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 3-188 Eprolin (vitamin E) Lilly Research Capsules. Laboratories, Lilly Corporate Center, Indianapolis, IN 46285. NDA 8-317 ACTH Injection King Pharmaceuticals, (corticotropin for Inc., 501 Fifth St., injection USP). Bristol, TN 37620. NDA 8-682 Thytropar (thyrotropin Aventis Pharmaceuticals, for injection). Inc., 399 Interpace Pkwy., P.O. Box 663, Parsippany, NJ 07054. NDA 9-766 Meticorten (prednisone) Schering Corp., 2000 Tablets. Galloping Hill Rd., Kenilworth, NJ 07033. NDA 12-034 Permitil (fluphenazine Do. hydrochloride (HCl)) Tablets. NDA 14-394\1\ Xylocaine (lidocaine), AstraZeneca, L.P., 725 10% Oral Spray. Chesterbrook Blvd., Wayne, PA 19087-5677. NDA 15-874 Alupent (metaproterenol Boehringer Ingelheim sulfate USP) Tablets, Pharmaceuticals, Inc., 10 milligrams (mg) and 900 Ridgebury Rd., P.O. 20 mg. Box 368, Ridgefield, CT 06877. NDA 17-056 Follutein (chorionic Bristol-Myers Squibb gonadotropin for Pharmaceutical Research injection USP) Institute, P.O. Box Injection. 4000, Princeton, NJ 08543-4000. NDA 17-316 Sodium Iodide I-131 CIS Bioindustries, c/o Capsules. CIS-US, Inc., 101 De Angelo Dr., Bedford, MA 01730. NDA 17-571 Alupent (metaproterenol Boehringer Ingelheim sulfate) Syrup, 10 mg/5 Pharmaceuticals, Inc. milliliters (mL). NDA 17-695 Antuitrin-S (chorionic Parke-Davis, 201 Tabor gonadotropin), 5,000 Rd., Morris Plains, NJ units. 07950. NDA 17-726 Asellacrin (somatropin) Serono, Inc., 100 Injection. Longwater Circle, Norwell, MA 02061. NDA 18-821 Reglan (metoclopramide) A.H. Robbins, c/o Wyeth- Syrup. Ayerst Research, P.O. Box 8299, Philadelphia, PA 19101-8299. NDA 19-368 Moctanin (monoctanoin). Ethitek Pharmaceuticals Co., 3 Court of Overlook Bluff, Northbrook, IL 60062. NDA 20-200 Nalbuphine HCl Abbott Laboratories, 200 Injection, 1.5 mg/mL. Abbott Park Rd., Abbott Park, IL 60064-3537. NDA 20-417 FemPatch (estradiol) Parke-Davis, 2800 Transdermal System. Plymouth Rd., Ann Arbor, MI 48105. ANDA 60-004 V-Cillin K (penicillin V Eli Lilly and Co., Lilly potassium USP) Powder Corporate Center, for Oral Solution, 125 Indianapolis, IN 46285. mg/5 mL and 250 mg/5 mL. ANDA 60-463 Garamycin (gentamicin Schering Corp. sulfate ointment USP) Ointment, 0.1%. ANDA 60-781 Penicillin G Potassium Mylan Pharmaceuticals, Tablets USP. Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26504-4310. ANDA 61-624 Penicillin V Potassium Do. for Oral Solution USP, 125 mg/5 mL and 250 mg/ 5 mL. ANDA 63-017 Cefadroxil Capsules USP, Purpac Pharmaceutical 500 mg. Co., 200 Elmora Ave., Elizabeth, NJ 07207. ANDA 63-119 Tombramycin Sulfate AstraZeneca, L.P., 1800 Injection USP, 10 mg/ Concord Pike, mL. Wilmington, DE 19803- 8355. ANDA 63-265 Amikacin Sulfate Abbott Laboratories. Injection USP. ANDA 63-266 Amikacin Sulfate Do. Injection USP. ANDA 63-295 Monocid (cefonicid for GlaxoSmithKline, One injection USP), 1 gram Franklin Plaza, P.O. (g) vials. Box 7929, Philadelphia, PA 19101-7929. ANDA 70-125 Propranolol HCl Tablets Lederle Laboratories, c/ USP, 10 mg. o ESI Lederle, P.O. Box 41502, Philadelphia, PA 19101-7929. ANDA 70-127 Propranolol HCl Tablets Do. USP, 40 mg. ANDA 70-629 Ibuprofen Tablets USP, Do. 400 mg. ANDA 70-630 Ibuprofen Tablets USP, Do. 600 mg. ANDA 70-636 Fentanyl Citrate Abbott Laboratories. Injection USP, 0.05 mg/ mL. ANDA 70-637 Fentanyl Citrate Do. Injection USP, 0.05 mg/ mL. [[Page 63108]] ANDA 71-065 Ibuprofen Tablets USP, Lederle Laboratories. 200 mg. ANDA 72-045 Haloperidol Intensol Roxane Laboratories, Oral Concentrate Inc., P.O. Box 16532, (haloperidol oral Columbus, OH 43216. solution USP), 2 mg/mL. ANDA 72-768 Sulfamethoxazole and Do. Trimethoprim Tablets USP, 400 mg/80 mg. ANDA 73-528 Loperamide HCl Tablets Able Laboratories, Inc., USP, 2 mg. l6 Hollywood Court, South Plainfield, NJ 07080-4295. ANDA 73-590 Lactulose Solution USP, Roxane Laboratories. 10 g/15 mL. ANDA 74-638 Iopamidol Injection USP, Abbott Laboratories. 61%. ANDA 74-662 Ranitidine Tablets USP, Boehring Ingelheim 150 mg and 300 mg. Corp., c/o Roxane Laboratories, Inc., P.O. Box 16532, Columbus, OH 43216- 6532. ANDA 75-230 Ketorolac Tromethamine Bedford Labs, 300 Injection USP, 15 mg/mL Northfield Rd., and 30 mg/mL. Bedford, OH 44146. ANDA 75-249 Midazolam HCl Injection, Do. 5 mg (base)/mL. ANDA 75-455 Midazolam HCl Injection Ben Venue Laboratories, 5 mg (base)/mL. Inc., 300 Northfield Rd., Bedford, OH 44146. ANDA 80-256 Methyltestosterone Eli Lilly and Co. Tablets USP, 10 mg and 25 mg. ANDA 83-799 Imipramine HCl Tablets Roxane Laboratories. USP, 25 mg and 50 mg. ANDA 87-743 Roxiprin Tablets Do. (oxycodone and aspirin tablets USP). ANDA 89-239 Mannitol Injection USP, AstraZeneca, L.P. 25%. ANDA 89-240 Mannitol Injection USP, Do. 25%. ------------------------------------------------------------------------ \1\ While NDA 14-394 was named in the Federal Register withdrawal notice of April 30, 1984 (49 FR 18357), this NDA was never withdrawn and remained active until 1999. 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 November 12, 2002. Dated: September 27, 2002. Janet Woodcock, Center for Drug Evaluation and Research. [FR Doc. 02-25882 Filed 10-9-02; 8:45 am] BILLING CODE 4160-01-S?