[Federal Register Volume 64, Number 183 (Wednesday, September 22, 1999)]
[Notices]
[Pages 51325-51326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-24595]



[[Page 51325]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99N-4004]


Wallace Laboratories et al.; Withdrawal of Approval of 18 New 
Drug Applications and 44 Abbreviated 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 18 new drug applications (NDA's) and 44 abbreviated new drug 
applications (ANDA'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requested that the approval of the applications be withdrawn.

EFFECTIVE DATE:  September 22, 1999.
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.

 
----------------------------------------------------------------------------------------------------------------
    Application No.                         Drug                                      Applicant
----------------------------------------------------------------------------------------------------------------
NDA 4-253               Davitamin Tablets                            Wallace Laboratories, 301B College Rd.,
                                                                      East, Princeton, NJ 08540.
NDA 5-932               5% Aminosol                                  Abbott Laboratories, One Abbott Park Rd.,
                                                                      Abbott Park, IL 60064-3500.
NDA 6-668               Redisol (cyanocobalamin) Tablets and         Merck & Co., Inc., 5 Sentry Pkwy., East
                         Injection.                                   (BLA-10), Blue Bell, PA 19422.
NDA 7-842               Flaxedil (gallamine triethiodide             Kendall Healthcare Products Co., 15
                         injection), 20 milligrams (mg)/milliter      Hampshire St., Mansfield, MA 02048.
                         (mL).
NDA 9-295               Vibazine (buclizine hydrochloride) Tablets.  Pfizer Pharmaceuticals, 235 East 42d St.,
                                                                      New York, NY 10017-5755.
NDA 10-460              Preludin (phenmetrazine hydrocholoride)      Boehringer Ingelheim Pharmaceuticals, Inc.,
                         Tablets.                                     900 Ridgebury Rd., P.O. Box 368,
                                                                      Ridgefield, CT 06877.
NDA 10-639              Hydeltrasol (prednisolone sodium phosphate   Merck & Co., Inc., P.O. Box 4, BLA-20, West
                         ophthalmic solution) Sterile Ophthalmic      Point, PA 19486.
                         Solution.
NDA 11-612              Daricon (oxyphenylcyclamine hydrochloride)   Pfizer Pharmaceuticals.
                         Tablets.
NDA 11-752              Preludin (phenmetrazine hydrochloride)       Boehringer Ingelheim Pharmaceuticals, Inc.
                         Endurets.
NDA 17-497              Synthetic Calcimar (calcitonin-salmon) for   Rhone-Poulenc Rorer Pharmaceuticals, Inc.,
                         Injection.                                   500 Arcola Rd.,P.O. Box 1200,
                                                                      Collegeville, PA 19426-0107.
NDA 18-208              Pfi-Lith (lithium carbonate) Capsules.       Pfizer Pharmaceuticals.
NDA 18-237              Calciparine (heparin calcium) Injection.     Sanofi Pharmaceuticals, Inc., 90 Park Ave.,
                                                                      New York, NY 10019.
NDA 18-342              Wellcovorin (leucovorin calcium) Tablets.    Glaxo Wellcome, Inc., 5 Moore Dr., P.O. Box
                                                                      13398, Research Triangle Park, NC 27709.
NDA 18-499              Lactated Ringer's and Dextrose Injection     Miles, Inc., Pharmaceutical Div., 4th and
                         USP.                                         Parker Sts., P.O. Box 1986, Berkeley, CA
                                                                      94701.
NDA 18-933              MVI-12 Powder                                Astra USA, Inc., P.O. Box 4500,
                                                                      Westborough, MA 01581-4500.
NDA 19-498              Parathar (teriparatide acetate) for          Rhone-Poulenc Rorer Pharmaceuticals, Inc.
                         Injection.
NDA 20-841              Lotemax (loteprednol etabonate ophthalmic    Pharmos Corp., c/o Bausch & Lomb
                         suspension), 0.5% Ophthalmic Suspension.     Pharmaceuticals, Inc., 8500 Hidden River
                                                                      Pkwy., Tampa, FL 33637.
NDA 50-762              Trovan/Zithromax Compliance Pak              Pfizer Pharmaceuticals.
                         (trovafloxacin mesylate/azithromycin for
                         oral suspension).
ANDA 60-082             Tetracyn (tetracycline) Capsules.            Pfizer, Inc., 235 East 42d St., New York,
                                                                      NY 10017-5755.
ANDA 60-290             Tetracycline Hydro-chloride Capsules USP,    Purepac Pharmaceutical Co., 200 Elmora
                         250 mg and 500mg.                            Ave., Elizabeth, NY 07207.
ANDA 60-458             Terramycin (oxytetracyclinewith polymyxin B  Pfizer, Inc.
                         sulfate) Topical Powder with Polymyxin B
                         Sulfate.
ANDA 60-586             Terramycin (oxytetracycline) IV.             Do.
ANDA 60-595             Terramycin (oxytetracycline) Syrup.          Do.
ANDA 60-731             Bacitracin Neomycin-Polymyxin with           Altana, Inc., 60 Baylis Rd., Melville, NY
                         Hydrocortisone Acetate Ophthalmic Ointment   11747.
                         1%.
ANDA 61-009             Terra-Poly (oxytetracycline, polymyxin B     Pfizer, Inc.
                         sulfate) Vaginal Tablets.
ANDA 61-010             Terramycin (oxytetracycline) Tablets.        Do.
ANDA 61-277             Penicillin G Potassium Tablets for Oral      Teva Pharmaceuticals, USA, 1510 Delp Dr.,
                         Solution USP.                                Kulpsville, PA 19443.
ANDA 61-841             Terramycin (oxytetracycline) with Polymyxin  Pfizer, Inc.
                         B Sulfate Otic Ointment.
ANDA 62-288             Gentamicin Sulfate Injection, 40 mg/mL.      Bristol Laboratories, P.O. Box 4755,
                                                                      Syracuse, NY 13221-4755.
ANDA 62-289             Gentamicin Sulfate Injection USP.            King Pharmaceuticals, Inc., 501 Fifth St.,
                                                                      Bristol, TN 37620.
ANDA 62-598             Neomycin Sulfate-Triamcinolone Acetonide     Savage Laboratories, Inc., Division of
                         Cream.                                       Altana Inc., 60 Baylis Rd., Melville, NY
                                                                      11747.
ANDA 62-607             Neomycin Sulfate-Triamcinolone Acetonide     Pharmaderm, Division of Altana, Inc., 60
                         Ointment.                                    Baylis Rd.,Melville, NY 11747.

[[Page 51326]]

 
ANDA 70-656             Dopamine Hydrochloride Injection USP, 40 mg/ Abbott Laboratories.
                         mL.
ANDA 70-657             Dopamine Hydrochloride Injection USP, 80 mg/ Do.
                         mL.
ANDA 73-611             Diphenhydramine Hydrochloride Cough Syrup,   Cumberland-Swan, Inc., 1 Swan Dr., Smyrna,
                         12.5 mg/5 mL.                                TN 37167.
ANDA 80-195             Potassium Chloride Injection.                Miles, Inc.
ANDA 80-211             Prednisolone Tablets, 5 mg.                  Private Formulations, Inc., 460 Plainfield
                                                                      Ave., Edison, NJ 08818.
ANDA 80-830             Vitamin A Capsules USP, 15 mg.               Del Ray Labs, Inc., 22-20th Ave., NW.,
                                                                      Birmingham, AL 35215.
ANDA 83-021             Sulfacetamide Sodium Ophthalmic Solution     AKORN, Inc., 1222 West Grand, Decatur, IL
                         USP, 10%, 15%, and 30%.                      62526.
ANDA 83-256             Alcohol in Dextrose Injection USP, 5%/5%.    Baxter Healthcare Corp., Rte. 120 and
                                                                      Wilson Rd., Round Lake, IL 60073-0490.
ANDA 84-652             Chlorotrianisene Capsules USP, 12 mg.        Banner Pharmacaps, 200730 Dearborn St.,
                                                                      P.O. Box 2157, Chatsworth, CA 91313-2157.
ANDA 84-708             Triamcinolone Tablets, 2 mg.                 Roxane Laboratories, Inc., P.O. Box 16532,
                                                                      Columbus, OH 43216-6532.
ANDA 84-775             Triamcinolone Tablets, 4 mg.                 Teva Pharmaceuticals, USA.
ANDA 85-697             Phendimetrazine Tartrate Tablets, 35 mg      Private Formulations, Inc.
                         (pink).
ANDA 85-914             Phendimetrazine Tartrate Tablets, 35mg.      Manufacturing Chemist, Inc., c/o Integrity
                                                                      Pharmaceutical Corp., 5767 Thunderbird
                                                                      Rd., Indianapolis, IN 46236.
ANDA 86-192             Hydrochlorothiazide Tablets, 25 mg and 50    M. M. Mast & Co., 4152 Ruple Rd.,
                         mg.                                          Cleveland, OH 44121.
ANDA 86-217             Chlordiazepoxide Capsules, 10 mg.            Do.
ANDA 86-259             Trichlormethiazide, 4 mg.                    Do.
ANDA 86-521             Dextroamphetamine Sulfate Tablets, 5 mg.     Do.
ANDA 86-523             Phenazine Capsules, 35 mg.                   Do.
ANDA 86-524             Phenazine Capsules, 35 mg.                   Do.
ANDA 86-525             Phenazine Capsules, 35 mg.                   Do.
ANDA 86-787             Sustac (nitroglcerin) Extended-release Oral  Forest Laboratories, Inc., 909 Third Ave.,
                         Tablets, 10 mg.                              New York, NY 10022-4731.
ANDA 87-255             Quinidine Sulfate Tablets, 200 mg.           Solvay Pharmaceuticals, Inc., 901 Sawyer
                                                                      Rd., Marietta, GA 30062.
ANDA 87-229             Nitrobon (nitroglycerin extended-release     Inwood Laboratories, Inc., 909 Third Ave.,
                         capsules) Capsules.                          New York, NY 10022-4731.
ANDA 87-305             Phendimetrazine Tartrate Tablets, 35 mg.     M. M. Mast & Co.
ANDA 87-544             Nitrobon (nitroglycerin extended-release     Inwood Laboratories, Inc.
                         capsules) Capsules.
ANDA 87-917             Theophylline Syrup, 80 mg/15 mL.             Ferndale Laboratories, Inc., 780 West Eight
                                                                      Mile Rd., Ferndale, MI 48220.
ANDA 89-577             Hydrocortisone Sodium Succinate for          Abbott Laboratories.
                         Injection USP, 100 mg/mL.
ANDA 89-578             A-Hydrocort (Hydrocortisone Sodium           Do.
                         Succinate for Injection USP), 250 mg/vial.
ANDA 89-579             A-Hydrocort (Hydrocortisone Sodium           Do.
                         Succinate for Injection USP), 500 mg/vial.
ANDA 89-580             A-Hydrocort (Hydrocortisone Sodium           Do.
                         Succinate for Injection USP), 1 gram/vial.
----------------------------------------------------------------------------------------------------------------

    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 22, 1999.

    Dated: September 8, 1999.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 99-24595 Filed 9-21-99; 8:45 am]
BILLING CODE 4160-01-F