[Federal Register Volume 59, Number 48 (Friday, March 11, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-5634]
[[Page Unknown]]
[Federal Register: March 11, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0050]
Lilly Research Laboratories, et al.; Withdrawal of Approval of 57
Abbreviated Antibiotic 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 57 abbreviated antibiotic drug applications (AADA's). The holders of
the AADA's 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be withdrawn.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: April 11, 1994.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-360), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
SUPPLEMENTARY INFORMATION: The holders of the AADA's 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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AADA No. Drug Applicant
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60-002.............. Penicillin V Potassium Lilly Research
Pulvules. Laboratories, Lilly
Corporate Center,
Indianapolis, IN 46285.
60-060.............. Ampicillin Trihydrate SmithKline Beecham
Capsules, 250 and 500 Pharmaceuticals, One
milligrams (mg). Franklin Plaza, P.O.
Box 7929, Philadelphia,
PA 19101.
60-129.............. Sterile Ampicillin Valso Ltd., 11 Briga
Sodium, USP (Bulk). Lane, White Plains, NY
10605.
60-132.............. Sterile Chloramphenicol Angus Chemical Co., 1500
Sodium Succinate, USP. East Lake Cook Rd.,
Buffalo Grove, IL
60089.
60-197.............. Bacitracin, USP A.L. Laboratories, Inc.,
(Nonsterile Bulk). One Executive Dr., P.O.
Box 1399 Ft. Lee, NJ
07024.
60-209.............. Ampicillin for Oral Wyeth-Ayerst
Suspension, USP. Laboratories, P.O. Box
8299, Philadelphia, PA
19101-8299.
60-210.............. Griseofulvin Tablets, Do.
USP.
60-250.............. Erythromycin Abbott Laboratories, One
Ethylsuccinate Abbott Park Rd., Abbott
Injection, USP. Park, IL 60064-3500.
60-254.............. Dicloxacillin Sodium SmithKline Beecham.
Capsules.
60-264.............. Tyrothricin, USP (Bulk). Penick Corp., 158 Mt.
Olivet Ave., Newark, NJ
07114.
60-278.............. Tetracycline Oral The Upjohn Co., 7000
Suspension, USP. Portage Rd., Kalamazoo,
MI 49001.
60-320.............. Neomycin and Polymyxin B Do.
Sulfates and Bacitracin
Ointment, USP.
60-336.............. Bacitracin Zinc and Marion Merrell Dow,
Polymyxin B Sulfate Inc., Marion Park Dr.,
Ointment, USP. P.O. Box 9627, Kansas
City, MO 64134-0627.
60-342.............. Tetracycline Angus Chemical Co.
Hydrochloride.
60-343.............. Tetracycline Do.
Hydrochloride.
60-344.............. Tetracycline Do.
Hydrochloride.
60-364.............. Penicillin G Potassium Bristol-Myers Squibb,
Ointment. Pharmaceutical Research
Institute,
P.O. Box 4000,
Princeton, NJ 08543-
4000.
60-411.............. Streptomycin Suflate Wyeth-Ayerst
Injection, USP. Laboratories Inc.
60-414.............. Neomycin and Polymyxin B Procter & Gamble
Sulfates and Bacitracin Pharmaceuticals, P.O.
Ointment. Box 191, Norwich, NY
13815-0191.
60-415.............. Bacitracin Ointment, USP Do.
60-427.............. Neomycin and Polymyxin B Marion Merrell Dow, Inc.
Sulfates and Gramicidin
Ophthalmic Solution,
USP.
60-459.............. Bacitracin, Neomycin Byk-Gulden, Inc., 60
Sulfate, Polymyxin B Baylis Rd., P.O. Box
Sulfate, and Diperodon 2006, Melville, NY
Hydrochloride Ointment. 11747.
60-471.............. Tetracycline ICN Pharmaceuticals,
Hydrochloride Capsules, Inc., ICN Plaza, 3300
USP, 250 mg. Hyland Ave., Costa
Mesa, CA 92626.
60-479.............. Neomycin Sulfate The Upjohn Co.
Ointment, USP.
60-480.............. Neomycin Sulfate- Do.
Flurometholone.
60-481.............. Tetracyline Oral Do.
Suspension, USP.
60-515.............. Kanamycin Sulfate Apothecon, A Bristol-
Injection. Myers Squibb Co., P.O.
Box 4500, Princeton, NJ
08543-4500.
60-516.............. Kanamycin Sulfate Do.
Capsules, 500 mg.
60-556.............. Neomycin Sulfate, USP Penick Corp.
(Nonsterile Bulk).
60-558.............. Erythromycin Estolate Lilly Research
Oral Suspension, USP, Laboratories.
100 mg base/mL.
60-812.............. Chloramphenicol Marion Merrell Dow, Inc.
Hemisuccinate (Bulk).
60-828.............. Tetracycline Valso Ltd.
Hydrochloride, USP
(Bulk).
60-829.............. Tetracycline, USP (Bulk) Do.
61-137.............. Penicillin V (Bulk)..... Lilly Research
Laboratories.
61-525.............. Erythromycin Delayed- Richmar International,
Release Tablets, 250 mg. Inc., 1706 Birch Rd.,
McLean, VA 22101.
61-586.............. Neomycin Sulfate Eon Labs Manufacturing,
Tablets, 500 mg. Inc., 227-15 Conduit
Ave., Laurelton, NY
11413.
61-967.............. Chloramphenicol Merrell Dow
Palmitate (Bulk). Pharmaceuticals, Inc.,
2110 East Galbraith
Rd., Cincinnati, OH
45215.
62-177.............. Erythromycin Lilly Research
Ethylsuccinate Oral Laboratories.
Suspension, 200 mg/5
milliliters (mL) and
400 mg/5 mL.
62-261.............. Cephalexin Monohydrate Do.
(Bulk).
62-264.............. Gentamicin Sulfate Wyeth-Ayerst
Injection, USP. Laboratories.
62-381.............. Neomycin and Polymyxin B Pharmafair, Inc., 110
Sulfates, Bacitracin Kennedy Dr., Hauppauge,
Zinc, and NY 11788.
Hydrocortisone Topical
Ointment.
62-386.............. Neomycin and Polymyxin B Do.
Sulfates and Bacitracin
Zinc Ophthalmic
Ointment, USP.
62-389.............. Neomycin and Polymyxin B Do.
Sulfates, Bacitracin
Zinc, and
Hydrocortisone
Ophthalmic Ointment,
USP.
62-411.............. Neomycin and Polymyxin B Do.
Sulfates and
Dexamethasone
Ophthalmic Ointment,
USP.
62-428.............. Neomycin and Polymyxin B Do.
Sulfates and
Dexamethasone
Ophthalmic Suspension,
USP.
62-443.............. Gentamicin Sulfate Do.
Ophthalmic Ointment,
USP, 3 mg base/gram (g).
62-481.............. Erythromycin Ophthalmic Do.
Ointment, USP, 5 mg/g.
62-485.............. Erythromycin Topical Do.
Solution, USP, 1.5%.
62-547.............. Cephalothin Sodium and Abbott Laboratories,
5% Dextrose Injection, Inc., Hospital Products
USP. Division Abbott Park,
IL 60064.
62-548.............. Cephalothin Sodium and Do.
0.9% Sodium Chloride
Injection, USP.
62-603.............. Nystatin and Pharmaderm, A Division
Triamcinolone Acetonide of Altana Inc., 60
Ointment, USP. Bayliss Rd., Melville,
NY 11747.
62-617.............. Neomycin and Polymyxin B Pharmafair, Inc.
Sulfates and
Hydrocortisone Otic
Suspension.
62-623.............. Neomycin and Polymyxin B Do.
Sulfates and
Hydrocortisone
Ophthalmic Suspension,
USP.
62-848.............. Cefadroxil, USP (Bulk).. Valso Ltd.
62-894.............. Sterile Cefazolin Ben Venue Laboratories,
Sodium, USP 250 mg, 500 Inc., 270 Northfield
mg, 1 g, 5 g, and 10 g Rd., P.O. Box 46568,
per vial. Bedford, OH 44146-0568.
62-908.............. Clindamycin Phosphate The DuPont Merck
Injection, USP, 150 mg/ Pharmaceutical Co.,
mL. 1000 Stewart Ave.,
Garden City, NY 11530.
70-292.............. Carbachol Intraocular Pharmafair, Inc.
Solution, USP, 0.01%.
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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 AADA's listed above, and all amendments and supplements
thereto, is hereby withdrawn, effective April 11, 1994.
Dated: February 23, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-5634 Filed 3-10-94; 8:45 am]
BILLING CODE 4160-01-P