Document ID: FDA-2009-N-0444-0002
Agency: fda
Document Type: Notice
Title: Withdrawal of Approval of Five New Drug Applications: Schmid Laboratories, Inc. et al.
Posted Date: 2010-09-10T04:00Z

[Federal Register: September 10, 2010 (Volume 75, Number 175)]
[Notices]               
[Page 55334-55335]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10se10-63]                         

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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