[Federal Register Volume 65, Number 178 (Wednesday, September 13, 2000)]
[Notices]
[Pages 55264-55265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-23477-Filed]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1498]
Lilly Research Laboratories et al.; Withdrawal of Approval of 28
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 28 new drug applications (NDA'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withdrawn.
DATES: Effective September 30, 2000.
FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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.
[[Page 55265]]
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Application No. Drug Applicant
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NDA 4-038 Diethylstilbestrol (DES) Injection. Lilly Research Laboratories, Lilly Corporate
Center, Indianapolis, IN 46285.
NDA 4-039 DES Tablets. Do.
NDA 4-040 DES Suppository. Do.
NDA 4-041 DES Tablets. Do.
NDA 4-056 Stilbetin Tablets (Diethylstilbestrol Bristol-Myers Squibb Co., P.O. Box 4000,
Tablets USP). Princeton, NJ 08543-4000.
NDA 6-327 Isuprel (Isoproterenol Hydrochloride) Sanofi-Synthelabo, Inc., 90 Park Ave., New
Inhalation Solution. York, NY 10016-1389.
NDA 7-371 Mecostrin Injection (Dimethyl Bristol-Myers Squibb Co.
Tubocurarine Chloride).
NDA 8-392 Nydrazid (Isoniazid USP) Tablets, Do.
Syrup, Capsules.
NDA 9-052 Rezipas (Aminosalicylic Acid Resin Do.
Powder).
NDA 9-273 Rauwolfia Serpentina, 50-milligram Impax Laboratories, Inc., 30831 Huntwood Ave.,
(mg) and 100-mg Tablets, 35-mg Hayward, CA 94544.
Capsule.
NDA 9-627 Reserpine, 0.1-mg, 0.25-mg, 0.5-mg, Do.
and 1-mg Tablets.
NDA 10-010 Stilphostrol (Diethylstilbestrol Bayer Corp., 400 Morgan Lane, West Haven, CT
Diphosphate) Injection and Tablets. 06516-4175.
NDA 10-347 Delalutin (Hydroxyprogesterone Bristol-Myers Squibb Co.
Caproate Injection USP).
NDA 11-359 Ora-testryl (Fluoxymesterone Tablets Do.
USP).
NDA 11-642 Cardioquin (Quinidine Purdue Frederick Co., 100 Connecticut Ave.,
Polygalacturonate) 275-mg Tablets. Norwalk, CT 06850-3590.
NDA 11-745 Konakion (Phytonadione) Injection. Hoffman-La Roche, Inc., 340 Kingsland St.,
Nutley, NJ 07110.
NDA 12-248 Plegine (Phendimetrazine Tartate) Wyeth Ayerst Laboratories, P.O. Box 8299,
Tablets. Philadelphia, PA 19101-8299.
NDA 12-339 Bronkometer (Isoetharine Mesylate Sanofi-Synthelabo, Inc.
Inhalation Aerosol) and Bronkosol
(Isoetharine Hydrochloride Inhalation
Solution).
NDA 16-911 Delalutin (Hydroxyprogesterone Bristol-Myers Squibb Co.
Caproate Injection USP).
NDA 17-424 Septisol Foam (Hexachlorophene). Steris Corp., P.O. Box 147, St. Louis, MO
63166-0147.
NDA 18-672 Nitro IV 5 mg/milliliters (mL) G. Pohl-Boskamp GmbH & Co., Kieler Strasse 11,
Injection and Nitronal Injection. D-25551 Hohenlockstedt, Germany.
NDA 18-762 Brethaire (Terbutaline Sulfate) Novartis Pharmaceuticals Corp., 59 Route 10,
Inhalation Aerosol. East Hanover, NJ 07936-1080.
NDA 19-069 Mycelex (Clotrimazole) Vaginal Bayer Corp.
Tablets.
NDA 19-082 Dalgan (Dezocine) Injection, 5, 10, AstraZeneca LP, 725 Chesterbrook Blvd., Wayne,
and 15 mg/mL. PA 19087-5677.
NDA 19-174 Trandate HCT (Labetalol Hydrochloride/ Glaxo Wellcome, Inc., P.O. Box 13398, Research
Hydrochlorothiazide) Tablets. Triangle Park, NC 27709.
NDA 19-287 DIZAC (Diazepam Injectable Emulsion). Pharmacia & Upjohn, 7000 Portage Rd.,
Kalamazoo, MI 49001-0199.
NDA 20-559 Tritec (Ranitidine Bismuth Citrate) Glaxo Wellcome, Inc.
Tablets.
NDA 21-048 17-Estradiol Transdermal R. W. Johnson Pharmaceutical Research
System. Institute, 920 Route 202 South, P.O. Box 300,
Raritan, NJ 08869-0602.
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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
September 30, 2000.
Dated: September 5, 2000.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 00-23477-Filed 9-12-00; 8:45 am]
BILLING CODE 4160-01-F