Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2009-N-0444]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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 § 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 § 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.**
Application No.
Drug
ApplicantNDA 5-766
Ramses Vaginal Jelly
Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424NDA 7-220
Synthetic Vitamin A (vitamin A palmitate)
Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486NDA 8-595
Immolin Vaginal Cream Jel
Schmid Laboratories, Inc.NDA 8-612
Silicote (simethicone) Ointment
Arnar-Stone Laboratories, Inc., 601 East Kensington Rd., Mount Prospect, IL 60056( print page 55335)NDA 10-915
Q.E.D. Hairgroom (captan)
A.R. Winarick, Inc., 783 Palisade Ave., Cliffside, NJ 07010
 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 § 314.81. In addition, under § 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