[Federal Register Volume 67, Number 197 (Thursday, October 10, 2002)]
[Notices]
[Pages 63107-63108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-25882]



[[Page 63107]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0430]


Lilly Research Labs et al.; Withdrawal of Approval of 16 New Drug 
Applications and 30 Abbreviated New Drug Applications

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is withdrawing 
approval of 16 new drug applications (NDAs) and 30 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requested that the approval of the applications be withdrawn.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 November 12, 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 requests, waived 
their opportunity for a hearing.

------------------------------------------------------------------------
   Application No.              Drug                    Applicant
------------------------------------------------------------------------
NDA 3-188             Eprolin (vitamin E)       Lilly Research
                       Capsules.                 Laboratories, Lilly
                                                 Corporate Center,
                                                 Indianapolis, IN 46285.
NDA 8-317             ACTH Injection            King Pharmaceuticals,
                       (corticotropin for        Inc., 501 Fifth St.,
                       injection USP).           Bristol, TN 37620.
NDA 8-682             Thytropar (thyrotropin    Aventis Pharmaceuticals,
                       for injection).           Inc., 399 Interpace
                                                 Pkwy., P.O. Box 663,
                                                 Parsippany, NJ 07054.
NDA 9-766             Meticorten (prednisone)   Schering Corp., 2000
                       Tablets.                  Galloping Hill Rd.,
                                                 Kenilworth, NJ 07033.
NDA 12-034            Permitil (fluphenazine    Do.
                       hydrochloride (HCl))
                       Tablets.
NDA 14-394\1\         Xylocaine (lidocaine),    AstraZeneca, L.P., 725
                       10% Oral Spray.           Chesterbrook Blvd.,
                                                 Wayne, PA 19087-5677.
NDA 15-874            Alupent (metaproterenol   Boehringer Ingelheim
                       sulfate USP) Tablets,     Pharmaceuticals, Inc.,
                       10 milligrams (mg) and    900 Ridgebury Rd., P.O.
                       20 mg.                    Box 368, Ridgefield, CT
                                                 06877.
NDA 17-056            Follutein (chorionic      Bristol-Myers Squibb
                       gonadotropin for          Pharmaceutical Research
                       injection USP)            Institute, P.O. Box
                       Injection.                4000, Princeton, NJ
                                                 08543-4000.
NDA 17-316            Sodium Iodide I-131       CIS Bioindustries, c/o
                       Capsules.                 CIS-US, Inc., 101 De
                                                 Angelo Dr., Bedford, MA
                                                 01730.
NDA 17-571            Alupent (metaproterenol   Boehringer Ingelheim
                       sulfate) Syrup, 10 mg/5   Pharmaceuticals, Inc.
                       milliliters (mL).
NDA 17-695            Antuitrin-S (chorionic    Parke-Davis, 201 Tabor
                       gonadotropin), 5,000      Rd., Morris Plains, NJ
                       units.                    07950.
NDA 17-726            Asellacrin (somatropin)   Serono, Inc., 100
                       Injection.                Longwater Circle,
                                                 Norwell, MA 02061.
NDA 18-821            Reglan (metoclopramide)   A.H. Robbins, c/o Wyeth-
                       Syrup.                    Ayerst Research, P.O.
                                                 Box 8299, Philadelphia,
                                                 PA 19101-8299.
NDA 19-368            Moctanin (monoctanoin).   Ethitek Pharmaceuticals
                                                 Co., 3 Court of
                                                 Overlook Bluff,
                                                 Northbrook, IL 60062.
NDA 20-200            Nalbuphine HCl            Abbott Laboratories, 200
                       Injection, 1.5 mg/mL.     Abbott Park Rd., Abbott
                                                 Park, IL 60064-3537.
NDA 20-417            FemPatch (estradiol)      Parke-Davis, 2800
                       Transdermal System.       Plymouth Rd., Ann
                                                 Arbor, MI 48105.
ANDA 60-004           V-Cillin K (penicillin V  Eli Lilly and Co., Lilly
                       potassium USP) Powder     Corporate Center,
                       for Oral Solution, 125    Indianapolis, IN 46285.
                       mg/5 mL and 250 mg/5
                       mL.
ANDA 60-463           Garamycin (gentamicin     Schering Corp.
                       sulfate ointment USP)
                       Ointment, 0.1%.
ANDA 60-781           Penicillin G Potassium    Mylan Pharmaceuticals,
                       Tablets USP.              Inc., 781 Chestnut
                                                 Ridge Rd., P.O. Box
                                                 4310, Morgantown, WV
                                                 26504-4310.
ANDA 61-624           Penicillin V Potassium    Do.
                       for Oral Solution USP,
                       125 mg/5 mL and 250 mg/
                       5 mL.
ANDA 63-017           Cefadroxil Capsules USP,  Purpac Pharmaceutical
                       500 mg.                   Co., 200 Elmora Ave.,
                                                 Elizabeth, NJ 07207.
ANDA 63-119           Tombramycin Sulfate       AstraZeneca, L.P., 1800
                       Injection USP, 10 mg/     Concord Pike,
                       mL.                       Wilmington, DE 19803-
                                                 8355.
ANDA 63-265           Amikacin Sulfate          Abbott Laboratories.
                       Injection USP.
ANDA 63-266           Amikacin Sulfate          Do.
                       Injection USP.
ANDA 63-295           Monocid (cefonicid for    GlaxoSmithKline, One
                       injection USP), 1 gram    Franklin Plaza, P.O.
                       (g) vials.                Box 7929, Philadelphia,
                                                 PA 19101-7929.
ANDA 70-125           Propranolol HCl Tablets   Lederle Laboratories, c/
                       USP, 10 mg.               o ESI Lederle, P.O. Box
                                                 41502, Philadelphia, PA
                                                 19101-7929.
ANDA 70-127           Propranolol HCl Tablets   Do.
                       USP, 40 mg.
ANDA 70-629           Ibuprofen Tablets USP,    Do.
                       400 mg.
ANDA 70-630           Ibuprofen Tablets USP,    Do.
                       600 mg.
ANDA 70-636           Fentanyl Citrate          Abbott Laboratories.
                       Injection USP, 0.05 mg/
                       mL.
ANDA 70-637           Fentanyl Citrate          Do.
                       Injection USP, 0.05 mg/
                       mL.

[[Page 63108]]

 
ANDA 71-065           Ibuprofen Tablets USP,    Lederle Laboratories.
                       200 mg.
ANDA 72-045           Haloperidol Intensol      Roxane Laboratories,
                       Oral Concentrate          Inc., P.O. Box 16532,
                       (haloperidol oral         Columbus, OH 43216.
                       solution USP), 2 mg/mL.
ANDA 72-768           Sulfamethoxazole and      Do.
                       Trimethoprim Tablets
                       USP, 400 mg/80 mg.
ANDA 73-528           Loperamide HCl Tablets    Able Laboratories, Inc.,
                       USP, 2 mg.                l6 Hollywood Court,
                                                 South Plainfield, NJ
                                                 07080-4295.
ANDA 73-590           Lactulose Solution USP,   Roxane Laboratories.
                       10 g/15 mL.
ANDA 74-638           Iopamidol Injection USP,  Abbott Laboratories.
                       61%.
ANDA 74-662           Ranitidine Tablets USP,   Boehring Ingelheim
                       150 mg and 300 mg.        Corp., c/o Roxane
                                                 Laboratories, Inc.,
                                                 P.O. Box 16532,
                                                 Columbus, OH 43216-
                                                 6532.
ANDA 75-230           Ketorolac Tromethamine    Bedford Labs, 300
                       Injection USP, 15 mg/mL   Northfield Rd.,
                       and 30 mg/mL.             Bedford, OH 44146.
ANDA 75-249           Midazolam HCl Injection,  Do.
                       5 mg (base)/mL.
ANDA 75-455           Midazolam HCl Injection   Ben Venue Laboratories,
                       5 mg (base)/mL.           Inc., 300 Northfield
                                                 Rd., Bedford, OH 44146.
ANDA 80-256           Methyltestosterone        Eli Lilly and Co.
                       Tablets USP, 10 mg and
                       25 mg.
ANDA 83-799           Imipramine HCl Tablets    Roxane Laboratories.
                       USP, 25 mg and 50 mg.
ANDA 87-743           Roxiprin Tablets          Do.
                       (oxycodone and aspirin
                       tablets USP).
ANDA 89-239           Mannitol Injection USP,   AstraZeneca, L.P.
                       25%.
ANDA 89-240           Mannitol Injection USP,   Do.
                       25%.
------------------------------------------------------------------------
\1\ While NDA 14-394 was named in the Federal Register withdrawal notice
  of April 30, 1984 (49 FR 18357), this NDA was never withdrawn and
  remained active until 1999.

    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 
November 12, 2002.

    Dated: September 27, 2002.
Janet Woodcock,
Center for Drug Evaluation and Research.
[FR Doc. 02-25882 Filed 10-9-02; 8:45 am]
BILLING CODE 4160-01-S?