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Notice

Menley & James Laboratories, Inc. et al.; Withdrawal of Approval of Six New Drug Applications

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is withdrawing approval of six 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 October 10, 2007.

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FOR FURTHER INFORMATION CONTACT:

Florine P. Purdie, Center for Drug Evaluation and Research (HFD-7), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-2041.

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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 June 28, 2007 (72 FR 35498), FDA published a notice offering an opportunity for a hearing (NOOH) on a proposal to withdraw approval of six 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 part 314 (21 CFR 314) in § 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 six applications listed in the table of this document.

Application No.DrugApplicant
NDA 6-410Benzedrex (propylhexadrine) Nasal SprayMenley & James Laboratories, Inc., Commonwealth Corporate Center, 100 Tournament Dr., Horsham, PA 19044
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NDA 7-518Synthetic Vitamin APfizer Laboratories, Division of Pfizer, Inc., 235 East 42nd St., New York, NY 10017
NDA 8-837Isoniazid TabletsBarnes Hind, 895 Kifer Rd., Sunnyvale, CA 94806
NDA 8-851NDK Fluoride Dentifrice (sodium monofluorophosphate)NDK Co., c/o J.W. Emmer/Kenneth Emmer, 215 Genevieve Dr., Lafayette, LA 70503
NDA 9-395Paskalium (potassium aminosalicylate)Glenwood, 111 Cedar Lane, Englewood, NJ 07631
NDA 19-518Extra Strength Aim (sodium monofluorophosphate)Chesebrough-Ponds USA Co., 33 Benedict Pl., P.O. Box 6000, Greenwich, CT 06836-6000

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 October 10, 2007.

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Dated: September 24, 2007.

Douglas C. Throckmorton,

Deputy Director, Center for Drug Evaluation and Research.

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[FR Doc. E7-19865 Filed 10-9-07; 8:45 am]

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