[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withdrawn.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