[Federal Register Volume 59, Number 120 (Thursday, June 23, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-15248]
[[Page Unknown]]
[Federal Register: June 23, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 94N-0223]
Clay-Park Labs, Inc.; Withdrawal of Approval of Three Abbreviated
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of one abbreviated antibiotic drug application (AADA) and two
abbreviated new drug applications (ANDA's) held by Clay-Park Labs,
Inc., 1700 Bathgate Ave., Bathgate Industrial Park, Bronx, NY 10457
(Clay-Park). FDA is withdrawing approval of these applications because
of questions raised about the reliability of the data and information
submitted to FDA in support of the applications. Clay-Park requested
this withdrawal and in so doing has waived its opportunity for a
hearing.
EFFECTIVE DATE: June 23, 1994.
FOR FURTHER INFORMATION CONTACT: David T. Read, Center for Drug
Evaluation and Research (HFD-366), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-2041.
SUPPLEMENTARY INFORMATION: FDA is aware of discrepancies concerning the
data used to support approval of the following applications held by
Clay-Park:
1. AADA 62-186, Nystatin and Triamcinolone Acetonide Cream, 100,000
units per gram and 0.1%, a generic version of Squibb's Mycolog-II;
2. ANDA 71-478, Betamethasone Valerate Ointment, 0.1%, a generic
version of Schering's Valisone 0.1%; and
3. ANDA 71-790, Fluocinonide Cream, 0.05%, a generic version of
Syntex's Lidex 0.05%.
The discrepancies in the data submitted to obtain approval of the
applications listed above raise questions about the reliability of the
data. In a letter dated March 22, 1994, Clay-Park requested withdrawal
of these applications.
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 above, and all their amendments and
supplements, is hereby withdrawn, effective June 23, 1994. Distribution
in interstate commerce of the drug products covered by these
applications is unlawful.
Dated: May 11, 1994.
Murry M. Lumpkin,
Acting Director, Center for Drug Evaluation and Research
[FR Doc. 94-15248 Filed 6-22-94; 8:45 am]
BILLING CODE 4160-01-F
