2010-22603. Schmid Laboratories, Inc. et al.; Withdrawal of Approval of Five New Drug Applications

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	Applicant
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
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.