[Federal Register Volume 75, Number 175 (Friday, September 10, 2010)]
[Notices]
[Pages 55334-55335]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-22603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0444]
Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five
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 five new drug applications (NDAs) from multiple holders of
these applications. The basis for the withdrawals is that the holders
of the applications have repeatedly failed to file required annual
reports for the applications.
DATES: Effective September 10, 2010.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new drugs for human use are required to submit annual reports to
FDA concerning each of their approved applications in accordance with
Sec. 314.81 (21 CFR 314.81).
In the Federal Register of September 24, 2009 (74 FR 49760), FDA
published a notice offering an opportunity for a hearing (NOOH) on a
proposal to withdraw approval of five NDAs because the firms had failed
to submit the required annual reports for these applications. The
holders of these applications did not respond to the NOOH. Failure to
file a written notice of participation and request for hearing as
required by Sec. 314.200 (21 CFR 314.200) constitutes an election by
the applicant not to make use of the opportunity for a hearing
concerning the proposal to withdraw approval of the applications and a
waiver of any contentions concerning the legal status of the drug
products. Therefore, the Director, Center for Drug Evaluation and
Research, is withdrawing approval of the five applications listed in
table 1 of this document.
Table 1.
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Application No. Drug Applicant
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NDA 5-766 Ramses Vaginal Schmid Laboratories, Inc., Route
Jelly 46 West, Little Falls, NJ 07424
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NDA 7-220 Synthetic Vitamin A Merck & Co., Inc., 770 Sumneytown
(vitamin A Pike, P.O. Box 4, West Point, PA
palmitate) 19486
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NDA 8-595 Immolin Vaginal Schmid Laboratories, Inc.
Cream Jel
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NDA 8-612 Silicote Arnar-Stone Laboratories, Inc.,
(simethicone) 601 East Kensington Rd., Mount
Ointment Prospect, IL 60056
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[[Page 55335]]
NDA 10-915 Q.E.D. Hairgroom A.R. Winarick, Inc., 783 Palisade
(captan) Ave., Cliffside, NJ 07010
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The Director, Center for Drug Evaluation and Research, under
section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(e)), and under authority delegated by the Commissioner, finds that
the holders of the applications listed in this document have repeatedly
failed to submit reports required by Sec. 314.81. In addition, under
Sec. 314.200, we find that the holders of the applications have waived
any contentions concerning the legal status of the drug products.
Therefore, under these findings, approval of the applications listed in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective September 10, 2010.
Dated: August 31, 2010.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-22603 Filed 9-9-10; 8:45 am]
BILLING CODE 4160-01-S