[Federal Register Volume 66, Number 159 (Thursday, August 16, 2001)]
[Notices]
[Pages 43017-43019]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-20605]



[[Page 43017]]

-----------------------------------------------------------------------

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requested that the approval of the applications be withdrawn.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,  Schering Corp., 2000 Galloping Hill Rd.,
                          10 milligrams (mg) and 25 mg.                Kenilworth, NJ 07033.
----------------------------------------------------------------------------------------------------------------
NDA 5-963                Sodium Sulamyd (sulfacetamide sodium)        Do.
                          Ophthalmic Solution and Ointment.
----------------------------------------------------------------------------------------------------------------
NDA 6-325                Tubocurarine Chloride Injection.             Lilly Research Laboratories, Lilly
                                                                       Corporate Center, Indianapolis, IN 46285.
----------------------------------------------------------------------------------------------------------------
NDA 6-632                Metubine Iodide (metocurine iodide)          Do.
                          Injection.
----------------------------------------------------------------------------------------------------------------
NDA 6-772                Vasoxyl (methoxamine hydrochloride (HCl))    GlaxoSmithKline (GSK), P.O. Box 13398,
                          Injection.                                   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  Syncor International Corp., 6464 Canoga
                          Injection.                                   Ave., Woodland Hills, CA 91367.
----------------------------------------------------------------------------------------------------------------
NDA 8-592                Ravocaine HCl (propoxycaine HCl and          Eastman Kodak Co., Health Imaging, 343
                          procaine HCl, with nordefrin or              State St., Rochester, NY 14612-1122.
                          norepinephrine bitartrate).
----------------------------------------------------------------------------------------------------------------
NDA 9-127                Cortril (hydrocortisone) Tablets.            Pfizer, Inc., 235 East 42d St., New York,
                                                                       NY 10017.
----------------------------------------------------------------------------------------------------------------
NDA 9-130                Cortril (hydrocortisone acetate) Ophthalmic  Do.
                          Ointment.
----------------------------------------------------------------------------------------------------------------
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       Pfizer Pharmaceuticals, 235 East 42d St.,
                          Ointment.                                    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/  Schering Corp.
                          5 mL (milliliters).
----------------------------------------------------------------------------------------------------------------
NDA 11-679               Pentothal Sodium (thiopental sodium)         Abbott Laboratories, D-389, Bldg. AP30,
                          Suspension.                                  200 Abbott Park Rd., Abbott Park, IL
                                                                       60064-6157.
----------------------------------------------------------------------------------------------------------------
NDA 12-148               Oreticyl Tablets and Oreticyle Forte         Do.
                          (hydrochlorothiazide and deserpidine)
                          Tablets.
----------------------------------------------------------------------------------------------------------------
NDA 12-715               Gantanol (sulfamethoxazole) Tablets.         Hoffman-LaRoche, Inc.
----------------------------------------------------------------------------------------------------------------

[[Page 43018]]

 
NDA 13-056               Penthrane (methoxyflurane) Inhalation        Abbott Laboratories.
                          Liquid.
----------------------------------------------------------------------------------------------------------------
NDA 13-934               Stoxil (idoxuridine) Ophthalmic Solution,    SmithKline Beecham Pharmaceuticals, One
                          0.1%.                                        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,    SmithKline Beecham Pharmaceuticals.
                          0.5%.
----------------------------------------------------------------------------------------------------------------
NDA 17-255               DTPA (chelate) Multidose (kit for the         Nycomed Amersham Imaging, 101 Carnegie
                          preparation of Tc-99m pentetate              Center, Princeton, NJ 08540.
                          injection).
----------------------------------------------------------------------------------------------------------------
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    Nycomed Amersham Imaging.
                          (Tin Kit).
----------------------------------------------------------------------------------------------------------------
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   Novo Nordisk Pharmaceuticals, Inc., 100
                          human insulin) Injection.                    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   Hoffmann-LaRoche, Inc.
                          Tablets, 50 mg and 100 mg.
----------------------------------------------------------------------------------------------------------------
ANDA 40-059              Fluocinolone Acetonide Topical Solution      Bausch & Lomb Pharmaceuticals, Inc., 8500
                          USP, 0.01%.                                  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        Pharmacia & Upjohn Co., 7000 Portage Rd.,
                          Powder.                                      Kalamazoo, MI 49001.
----------------------------------------------------------------------------------------------------------------
NDA 50-683               Zefazone (cefmetazole sodium) Intraveous     Do.
                          Solution.
----------------------------------------------------------------------------------------------------------------
ANDA 60-760              Oxytetracycline HCl Capsules, 250 mg.        Impax Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 62-223              Totacillin (Ampicillin Trihydrate for Oral   SmithKline Beecham Pharmaceuticals.
                          Suspension USP).
----------------------------------------------------------------------------------------------------------------
ANDA 62-736              Bactocill (oxacillin sodium) Injection.      GlaxoSmithKline (GSK).
----------------------------------------------------------------------------------------------------------------
ANDA 64-055              Neomycin Sulfate and Dexamethosone Sodium    Bausch & Lomb Pharmaceuticals, Inc.
                          Phosphate Ophthalmic Solution
----------------------------------------------------------------------------------------------------------------

[[Page 43019]]

 
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                 Schering Corp.
                          (Methyltestosterone Tablets USP).
----------------------------------------------------------------------------------------------------------------
ANDA 80-780              Prednisolone Tablets USP, 5 mg.              Impax Laboratories, Inc.
----------------------------------------------------------------------------------------------------------------
ANDA 80-807              Diphenhydramine HCl Capsules USP, 25 mg and  Do.
                          50 mg.
----------------------------------------------------------------------------------------------------------------
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           Schwarz Pharma, Inc., P.O. Box 2038,
                          phenobarbital) Oral Solution.                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