Food and Drug Administration, HHS.
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.
Effective September 10, 2010.Start Further Info
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.End Further Info End Preamble Start Supplemental 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.
|NDA 5-766||Ramses Vaginal Jelly||Schmid Laboratories, Inc., Route 46 West, Little Falls, NJ 07424|
|NDA 7-220||Synthetic Vitamin A (vitamin A palmitate)||Merck & Co., Inc., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486|
|NDA 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|
|Start Printed 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.Start Signature
Dated: August 31, 2010.
Director, Center for Drug Evaluation and Research.
[FR Doc. 2010-22603 Filed 9-9-10; 8:45 am]
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