[Federal Register Volume 59, Number 61 (Wednesday, March 30, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-7501]
[[Page Unknown]]
[Federal Register: March 30, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 94N-0106]
Akorn, Inc., et al.; Withdrawal of Approval of 18 Abbreviated
Antibiotic 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 abbreviated antibiotic 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withdrawn.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 29, 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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60-198 Sterile Penicillin G Procaine Akorn, Inc., P.O. Box 1220,
Suspension, U.S.P.. Decatur, IL 62525.
60-209 Ampicillin for Oral Wyeth-Ayerst Laboratories,
Suspension, U.S.P.. P.O. Box 8299, Philadelphia,
PA 19101-8299.
60-362 Pencillin G Potassium for Apothecon, P.O. Box 4500,
Injection, U.S.P.. Princeton, NJ 08543-4500.
60-363 Penicillin G Sodium for Do.
Injection, U.S.P..
60-520 Neomycin Sulfate Tablets, The Upjohn Co., 7000 Portage
U.S.P.. Rd., Kalamazoo, MI 49001-
0199.
61-048 Neomycin and Polymyxin B Do.
Sulfates and Bacitracin
Ophthalmic Ointment, U.S.P.
61-140 Novobiocin Calcium, U.S.P., Do.
(bulk).
61-238 Bacitracin (nonsterile bulk).. Apothekernes Laboratorium,
A.S.,c/o A. L. Laboratories,
Inc., One Executive Dr.,
P.O. Box 1399, Ft. Lee, NJ
07024.
61-443 Tetracycline Hydrochloride Solvay Pharmaceuticals, 901
Capsules. Sawyer Rd., Marietta, GA
30062.
62-139 Sterile Minocycline Lederle Laboratories, 401
Hydrochloride, U.S.P., 100 North Middletown Rd., Pearl
milligrams (mg)/vial. River, NY 10965-1299.
62-322 Erythromycin Stearate Tablets, Warner-Chilcott Laboratories,
U.S.P.. 201 Tabor Rd., Morris
Plains, NJ 07950.
62-437 Chloramphenicol Ophthalmic Pharmafair, Inc., 110 Kennedy
Solution, U.S.P., 0.5%. Dr., Hauppauge, NY 11788.
62-439 Chloramphenicol Ophthalmic Do.
Ointment, U.S.P., 1%.
62-453 Bacitracin Ophthalmic Do.
Ointment, U.S.P..
62-546 Erythromycin Capsules, U.S.P., Parke-Davis, 2800 Plymouth
250 mg. Rd., Ann Arbor, MI 48105.
62-562 Amikacin Sulfate Injection, Apothecon.
U.S.P..
62-564 Kanamycin Sulfate Injection, Do.
U.S.P..
62-978 Cloxacillin Sodium Oral Novopharm Ltd., c/o Therese
Solution, U.S.P., 125 mg/5 M. Ast, 176 East 17th St.,
milliliters. New York, NY 10021.
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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 29, 1994.
Dated: March 15, 1994.
Murray M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research.
[FR Doc. 94-7501 Filed 3-29-94; 8:45 am]
BILLING CODE 4160-01-F