[Federal Register Volume 67, Number 82 (Monday, April 29, 2002)]
[Notices]
[Pages 20977-20978]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-10425]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 02N-0133]
Novartis Pharmaceuticals Corp. et al.; Withdrawal of Approval of
38 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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withdrawn.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.
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NDA No. Drug Applicant
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740 Ovocyclin Dipropionate Injection and Novartis Pharmaceuticals Corp., 59 Route 10, East
Di-Ovocyclin (Estradiol Dipropionate Hanover, NJ 07936.
NF).
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3-034 Bismakaolin. The Vale Chemical Co., Inc., 1201 Liberty St.,
Allentown, PA 18102.
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3-353 Tocopherex (Vitamin E) Capsules. E. R. Squibb & Sons, One Squibb Dr., P.O. Box 191, New
Brunswick, NJ 08903-0191.
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3-697 Comin Vitamin Capsules. Forest Pharmaceuticals, Inc., 150 East 58th St., New
York, NY 10155-0015.
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3-934 Avitol (Vitamin A) Capsules. Do.
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3-962 Sodium Pentobarbital Injection. Lakeside Laboratories, Milwaukee, WI 53201.
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3-993 Beminal Tablets. Whitehall Laboratories, 685 Third Ave., New York, NY
10017-4076.
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4-016 Tonajuve Liquid. Merrell-National Laboratories, Cincinnati, OH 45215.
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5-070 Privine (Naphazoline Hydrochloride Novartis Pharmaceuticals Corp.
USP).
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7-012 Vi-Twel (Cyanocobalamin Injection Berlex Laboratories, Inc., 300 Fairfield Rd., Wayne, NJ
USP). 07470-7358.
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8-070 Elkosin (sulfisomidine) Tablets and CIBA-GEIGY Corp.
Suspension.
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8-418 Pyribenzamine (Tripelennamine Novartis Pharmaceuticals Corp.
Hydrochloride USP) with Zirconium.
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8-729 Dorsacaine Ophthalmic Solution. Sandoz Research Institute, Route 10, East Hanover, NJ
07936.
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8-908 InfraRUB Cream. Whitehall Laboratories
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11-073 Wampocaps (niacin) Capsules. Wallace Laboratories, Cranbury, NJ 08512.
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11-123 Vesprin (triflupromazine Apothecon, P.O. Box 4500, Princeton, NJ 08543-4500.
hydrochloride).
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[[Page 20978]]
11-419 Sterisol Mouthwash and Gargle. Warner-Lambert Co., 170 Tabor Rd., Morris Plains, NJ
07950.
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12-542 Oxalid (oxyphenbutazone) Tablets. Novartis Pharmaceuticals Corp.
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13-273 Nitrofurantoin Tablets. Albran, Inc., 68-43 Juno St., Forest Hills, NY 11375.
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16-000 Sulla (sulfameter) Tablets Berlex Laboratories, Inc.
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17-071 Benzedrine (amphetamine sulfate) Smith Kline & French Laboratories, 1500 Spring Garden
Spansule Capsules. St., P.O. Box 7929, Philadelphia, PA 19101.
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17-098 Selenomethionine Se-75 Injection. Mallinckrodt, Inc., 675 McDonnell Blvd., P.O. Box 5840,
St. Louis, MO 63134.
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17-109 Prednisone Tablets USP, 20 milligrams Roxane Laboratories, Inc., P.O. 16532, Columbus, OH
(mg). 43216-6532.
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17-282 Technetium Tc-99m Sulfur Colloid Kit. E. I. duPont de Nemours & Co., Inc., 331 Treble Cove
Rd., North Billerica, MA 01862.
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17-454 Osteoscan (Technetium Tc-99m Mallinckrodt, Inc.
Etidronate Kit).
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17-518 Ytterbium Yb-169 DTPA. 3M Health Care Group, 3M Center, St. Paul, MN 55144-
1000.
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17-678 Technetium Tc-99m Pyrophosphate Kit. Syncor International Corp., 12847 Arroyo St., Sylmar,
CA 91342.
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17-704 Dantrium Oral Suspension. Norwich Easton Pharmaceuticals, Inc., P.O. Box 191,
Norwick, NY 13815-00191.
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18-102 Medrol (methylprednisolone acetate) The Upjohn Co., 7000 Portage Rd., Kalamazoo, MI 49001-
Enpak Kit. 0199.
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18-121 Catarase Ophthalmic Solution. Novartis Pharmaceuticals Corp.
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18-236 ZOMAX (zomepirac sodium) Tablets. The R. W. Johnson Pharmaceutical Research Institute,
Welsh and McKean Rds., Spring House, PA 19477-0776.
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18-297 Allopurinol Tablets USP, 100 and 300 Abbott Laboratories, 100 Abbott Park Rd., Abbott Park,
mg. IL 60064.
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19-421 Exidine Solution. Xttrium Laboratories, Inc., 415 West Pershing Rd.,
Chicago, IL 60609.
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50-043 Keflin (cephalothin sodium) Injection. Lilly Research Laboratories, Lilly Corprate Center,
Indianapolis, IN 46285.
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50-219 Kafocin. Do.
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50-469 Keflin, Frozen Neutral. Do.
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50-501 Velosef Injection. Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543-6837.
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50-540 Mandol Injection. Lilly Research Laboratories.
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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