[Federal Register Volume 62, Number 122 (Wednesday, June 25, 1997)] [Notices] [Pages 34297-34300] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 97-16609] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 87N-0262] Merck & Co., Inc., et al.; Withdrawal of Approval of 39 New Drug Applications, 13 Abbreviated Antibiotic Applications, and 46 Abbreviated New Drug Applications AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 39 new drug applications (NDA's), 13 abbreviated antibiotic applications (AADA's), and 46 abbreviated new drug applications (ANDA'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agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. EFFECTIVE DATE: July 25, 1997. FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, 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 had a hearing or have, by their request, waived their opportunity for a hearing. ------------------------------------------------------------------------ Application No. Drug Applicant ------------------------------------------------------------------------ NDA 1-205....................... Propadrine Merck & Co., Inc., (Phenylephrine P.O. Box 4, BLA- hydrochloride) 20, West Point, Elixir. PA 19486. NDA 5-151....................... Percorten Acetate Novartis, 556 (desoxy- Morris Ave., corticosterone Summit, NJ 07901- acetate, USP 1395. Pellets. NDA 5-587....................... Phisoderm Cream... Sterling Drug, Inc., 90 Park Ave., New York, NY 10016. NDA 5-786....................... Ceepryn Merrell Dow Concentrate Research Solution. Institute, 2110 E. Galbraith Rd., Cincinnati, OH 45215-6300. [[Page 34298]] NDA 7-085....................... Cyanocobalamin Warner Chilcott, Injection USP, Inc., Rockaway 80 1000 micrograms Corp. Center, 100 per milliliter Enterprise Dr., (mL). suite 280, Rockaway, NJ 07866. NDA 8-072....................... Peritrate Parke-Davis, 2800 (pentaerythritol Plymouth Rd., Ann tetranitrate) Arbor, MI 48105. Tablets, 10, 20, and 40 milligrams (mg). NDA 8-279....................... Nalline Injection. Merck & Co., Inc. NDA 8-319....................... Butazolidin Ciba Geigy Corp., Tablets and 556 Morris Ave., Capsules Summit, NY 07901- (phenylbutazone 1398. tablets and capsules). NDA 9-099....................... Bonine (meclizine Pfizer, Inc., 235 HCl)Chewable East 42d St., New Tablets. York, NY 10017- 5755. NDA 9-637....................... Hydrocortisone AC Akorn, Inc., P.O. Injection(hydroco Box 1220, rtisone acetate Decatur, IL injection). 62525. NDA 10-585...................... LERITINE Tablets.. Merck & Co., Inc. NDA 11-109...................... Peritrate SA Parke-Davis. Tablets, 80 mg. NDA 11-983...................... Decadron Topical Merck & Co., Inc. Cream. NDA 12-108...................... Vaga Spray........ Menlo Park Laboratories, Inc., 459 Amboy Ave., P.O. Box 648, Woodbridge, NJ 07095. NDA 12-311...................... Pentritol Rhone-Poulenc (pentaerythritol Rorer tetranitrate) Pharmaceuticals Timed Release Inc., 500 Arcola Tempules 60 mg. Rd., P.O. Box 1200, Collegeville, PA 19426-0107. NDA 12-487...................... Taractan Hoffmann-La Roche, (chlorprothixene Inc., 340 Ampuls). Kingsland St., Nutley, NJ 07110- 1199. NDA 16-219...................... Lemon Spree Colgate-Palmolive Deodorant Soap. Co., 909 River Rd., P.O. Box 1343, Piscataway, NJ 08855-1343. NDA 16-264...................... Palmolive Gold Do. Antibacterial Deodorant Soap. NDA 16-278...................... Tackle Medicated Do. Soap. NDA 16-457...................... Pentritol Rhone-Poulenc (pentaerythritol Rorer tetranitrate) Pharmaceuticals Timed Release Inc. Tempules 30 mg. NDA 16-486...................... P-300 Colgate-Palmolive Antibacterial Co. Deodorant Soap. NDA 16-818...................... Emete-con Pfizer, Inc. (benzquinmide HCl) Suppositories. NDA 17-818...................... HALOG Westwood-Squibb (halcinonide) Pharmaceuticals Cream, 0.025%. Inc., 100 Forest Ave., Buffalo, NY 114213-1091. NDA 17-914...................... OTIC-TRIDESILON Bayer Corp., 400 (desonide-acetic Morgan Lane, West acid) Solution, Haven, CT 06516- 0.05%. 4175 NDA 18-040...................... Monistat Janssen, 1125 (miconazole) i.v.. Trenton- Harbourton Rd., P.O. Box 200, Titusville, NJ 08560-0200. NDA 18-793...................... Cold Capsule IV D. M. Graham (phenyl- Laboratories, propanolamine Inc., 58 Pearl hydro-chloride 75 St., Hobart, NY mg and 13788. chlorpheniramine maleate 12 mg extended-release capsules). NDA 18-794...................... Cold Capsule V Do. (phenylpropanolam ine hydrochloride 75 mg and chlorpheniramine maleate 8 mg extended-release capsules). NDA 18-843...................... Pseudoephrine Do. hydrochloride 120 mg and chlorpheniramine maeleate 12 mg extended-release capsules. NDA 18-844...................... Pseudoephredrine Do. hydrochloride 120 mg and chlorpheniramine mealeate 8 mg extended-release capsules. NDA 50-165...................... Polysporin Burroughs Wellcome Ointment. Co., 3030 Cornwallis Rd., P.O. Box 12700, Research Triangle Park, NC 27709- 2700. NDA 50-166...................... Polysporin Topical Do. Powder. NDA 50-170...................... Neosporin Ointment Do. NDA 50-313...................... Fungizone Ointment Apothecon, P.O. Box 4500, Princeton, NJ 08543-4500. NDA 50-323...................... NEODECADRON Merck &. Co., Inc. Topical Cream. NDA 50-325...................... NEODECASPRAY Do. Topical Aerosol. NDA 50-459...................... Amoxil SmitheKline (amoxicillin Beecham, One trihydrate) Franklin Plaza, capsules. P.O. Box 7929, Philadelphia, PA 19101. NDA 50-460...................... Amoxicillin Do. trihydrate for oral suspension. NDA 50-601...................... Ceradon (Cefotiam Takeda Chemical HCl for Industries Ltd. c/ Injection). o Corning Besselaar, Inc., 210 Carnegie Center, Princeton, NJ 08540-6233. NDA 50-678...................... DYNABAC Lilly Research (dirithromycin Laboratories, tablets). Lilly Corporate Center, Indianapolis, IN 46285. AADA 60-095..................... Tetracycline Pfizer, Inc. Suspension 100 mg/ mL and Tetracycline Suspension 125 mg/ 5 mL. AADA 60-199..................... Chloramphenicol Chong Kun Dang Palmitate USP Corp., 14 Magnet (nonsterile bulk). St., Stony Brook, NY 11790. AADA 60-200..................... Chloramphenicol Do. USP, non-sterile bulk. AADA 60-285..................... Tetracycline Pfizer, Inc. Hydrochloride Intramuscular Injection, 100 mg and 250 mg vials (both with Procaine Hydrochloride 2%). AADA 60-436..................... Chloraphenicol Chong Kun Dang Sodium Succinate Corp. USP, (Sterile bulk). AADA 61-606..................... Pyocidin-Otic Forest (Polymyxin B Laboratories, Sulfate and Inc., 909 Third Hydrocortisone Ave., New York, Otic Solution NY 10022-4731. USP); 10,000 units and 5 mg/ mL). AADA 62-077..................... Ampicillin Sandoz Anhydrous (bulk). Pharmaceutical, Agent for Roferm S.p.A., 59 Route 10, East Hanover, NJ 07936-1080. [[Page 34299]] AADA 62-174..................... Erythromycin Pharmacia & Ethylsuccinate, Upjohn, 7000 USP (nonsterile Portage Rd., bulk). Kalamzoo, MI 49001-0199. AADA 62-301..................... Chloramphenacol Parke-Davis. Palmitate Suspension USP, 150 mg/5 mL. AADA 62-647..................... Amoxicillin Sandoz Trihydrate (bulk). Pharmaceuticals, Agent for Roferm S.p.A. AADA 62-794..................... Clindamycin Biochimica Opos Phosphate USP, S.p.A., c/o nonsterile bulk. Kleinfeld, Kaplan, and Becker, 1140 Nineteenth St. NW., suite 900,Washington, DC 20036. AADA 63-130..................... Minocycline Do. Hydrochloride (bulk, nonsterile). AADA 64-072..................... Cefaclor USP, Do. (bulk, nonsterile). ANDA 70-516..................... Propranolol Roxane Hydrochloride Laboratories, Tablets USP, 10 Inc., P.O. Box mg. 16532, Columbus, OH 43216-6532. ANDA 70-517..................... Propranolol Do. Hydrochloride Tablets USP, 20 mg. ANDA 70-518..................... Propranolol Do. Hydrochloride Tablets USP, 40 mg. ANDA 70-519..................... Propranolol Do. Hydrochloride Tablets USP, 60 mg. ANDA 70-521..................... Propranolol Do. Hydrochloride Tablets USP, 90 mg. ANDA 71-555..................... Nitropress Abbott (Sterile Sodium Laboratories, D- Nitroprusside, 389 Bldg., AP30, USP) 50 mg vial. 200 Abbott Park Rd., Abbott Park, IL 60064-3537. ANDA 80-368..................... Isoniazid Tablets Vintage USP, 50 mg and Pharmaceuticals, 100 mg. Inc., 3241 Woodpark Blvd., Charlotte, NC 28206. ANDA 80-778..................... Hydroxcobalamin Merck & Co., Inc. Injection (Alpha Redisol). ANDA 83-089..................... Propoxyphene Roxane Hydrochloride Laboratories, Capsules USP, 65 Inc. mg. ANDA 84-772..................... Promethazine Alpharma, U.S. Hydrochloride Pharmaceuticals Syrup USP, 25 mg/ Division, 333 5 mL. Cassell Dr., suite 3500, Baltimore, MD 21224. ANDA 85-169..................... Theophylline Halsey Drug Col, Elixir, 80 mg/15 Inc., 1827 mL. Pacific St., Brooklyn, NY 11233-3599. ANDA 85-263..................... Theophylline KV Pharmaceutical Capsules, 100 mg Co., 2503 South and 200 mg. Hanely Rd., St. Louis, MO 63144- 2555. ANDA 85-364..................... Acetaminophen and Do. Codeine Phosphate Tablets, USP (300 mg/15 mg). ANDA 85-365..................... Acetaminophen and Do. Codeine Phosphate Tablet, USP (300 mg/60 mg). ANDA 85-523..................... Meclinzine Do. Hydrochloride Tablets USP, 25 mg. ANDA 85-524..................... Meclizine Do. Hydrochloride Tablets USP, 12.5 mg. ANDA 85-525..................... Phendimetrazine Do. Tartrate Tablets USP, 35 mg. ANDA 85-555..................... Cyclopentolate Akorn Hydrochloride Manufacturing, Opthalmic Inc. Solution USP, 1%. ANDA 85-658..................... Methocarbamol KV Pharmaceutical Tablets, USP (705 Co. mg). ANDA 85-659..................... Diphenoxylate Do. Hydrochloride and Atropine Sulfate Tablets USP, 2.5 mg/0.25 mg. ANDA 85-660..................... Methocarbamol Do. Tablets, USP (500 mg). ANDA 86-264..................... Ergoloid Mesylates Do. Sublingual Tablets (1.0 mg). ANDA 86-265..................... Ergoloid Mesylates Do. Sublingual Tablets (0.5 mg). ANDA 86-737..................... Cyproheptadine KV Pharmaceutical Hydrochloride Co. Tablets USP, 4 mg. ANDA 86-760..................... Phyllocontin The Perdue (Aminophylline Frederick Co., Controlled- 100 Connecticut release Tablets), Ave., Norwalk, CT 225 mg. 06850-3590. ANDA 87-164..................... Chlorpheniramine Do. Maleate Tablets USP, 4 mg. ANDA 87-193..................... Theophylline D. M. Graham Extended-release Laboratories, Capsules, 250 mg. Inc. ANDA 87-194..................... Theophylline Do. Extended-release Capsules, 100 mg. ANDA 87-195..................... Diphenoxylate ICN Hydrochloride Pharmaceuticals, with Atropine Inc., ICN Plaza, Sulfate Tablets, 3300 Hyland Ave, 2.5 mg/0.025 mg. Costa Mesa, CA 92626. ANDA 87-243..................... Aminophyllin G. D. Searle and Injection, USP. Co., 4901 Searle Pkwy., Skokie, IL 60077. ANDA 87-464..................... Oxycodone and Halsey Drug Co., Aspirin Tablets, Inc. 4.5 mg/235 mg. ANDA 87-763..................... Theophylline D.M. Graham Extended-release Laboratories, Capsules, 50 mg. Inc. ANDA 88-020..................... Trimcaps Do. (Phendimetrazine Tartrate Extended- release Capsules, 105 mg). ANDA 88-028..................... Dital Do. (Phendimetrazine Tartrate Extended- release Capsules, 105 mg). ANDA 88-063..................... Dyrexan-OD Do. (Phendimetrazine Tartrate Extended- release Capsules, 105 mg). ANDA 88-111..................... Rexigen Forte Do. (Phendimetrazine Tartrate Extended- release Capsules, 105 mg). ANDA 88-377..................... Propantheline Par Bromide Tablets, Pharmaceutical, 15 mg. Inc., One Ram Ridge Rd., Spring Valley, NY 10977. ANDA 88-382..................... Theophylline D. M. Graham Extended-release Laboratories, Capsules, 200 mg. Inc. ANDA 88-383..................... Theophylline Do. Extended-release Capsules, 300 mg. ANDA 88-577..................... Hydrocodone Barr Laboratories, Bitartrate and Inc., Two Quaker Acetaminophen Rd., P.O. Box Tablets USP, 5 mg/ 2900, Pomona, NY 500 mg. 10970-0519. ANDA 88-689..................... Theophylline Central Extended release Pharmaceutical, Capsules USP, 250 Inc., 120 East mg. Third St., Seymour, IN 47274- 0328 ANDA 88-743..................... Endolor D. M. Graham (Butalbital, Laboratories, Acetaminophen, Inc. and Caffeine Capsules USP, 50 mg/325 mg/40 mg. [[Page 34300]] ANDA 88-765..................... Two-Dyne Do. (Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/325 mg/40 mg. ANDA 89-067..................... Margesic Do. (Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/325 mg/40 mg. ANDA 89-605..................... Prochlorperazine Steris Edisylate Laboratories, Injection USP, 5 Inc., 620 North mg/mL. 51st Ave., Pheonix, AZ 85040- 4705. ANDA 89-994..................... Oxycodone Halsey Drug Co., Hydrochloride and Inc. Acetaminophen Capulses, 5 mg/ 500 mg. ------------------------------------------------------------------------ NDA's 8-072, 11-983, 12-311, and 16-457 were the subject of a hearing (Docket No. 87N-0262 (52 FR 32170, August 26, 1987)). The initial decision of the Administrative Law Judge (ALJ) was that the drug products covered by the NDA's lacked substantial evidence of effectiveness. The holder of NDA's 12-311 and 16-457 was stricken as a party participant in the hearing for failure to file a notice of participation, and the holder of NDA's 8-072 and 11-983 has formally withdrawn its appeal of the initial decision of the ALJ. This notice, therefore, constitutes final agency action on Docket No. 87N-0262 insofar as these four NDA's. Therefore, under section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(e)) approval of the applications listed in the table in this document, and all amendments and supplements thereto, is hereby withdrawn, effective July 25, 1997. Dated: June 17, 1997. William K. Hubbard, Associate Commissioner for Policy Coordination. [FR Doc. 97-16609 Filed 6-24-97; 8:45 am] BILLING CODE 4160-01-F