[Federal Register Volume 72, Number 195 (Wednesday, October 10, 2007)]
[Notices]
[Pages 57586-57587]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19865]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0246]


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

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.

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.

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 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 Sec.  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.             Drug                      Applicant
------------------------------------------------------------------------
NDA 6-410         Benzedrex                   Menley & James
                   (propylhexadrine) Nasal     Laboratories, Inc.,
                   Spray                       Commonwealth Corporate
                                               Center, 100 Tournament
                                               Dr., Horsham, PA 19044
------------------------------------------------------------------------

[[Page 57587]]

 
NDA 7-518         Synthetic Vitamin A         Pfizer Laboratories,
                                               Division of Pfizer, Inc.,
                                               235 East 42nd St., New
                                               York, NY 10017
------------------------------------------------------------------------
NDA 8-837         Isoniazid Tablets           Barnes Hind, 895 Kifer
                                               Rd., Sunnyvale, CA 94806
------------------------------------------------------------------------
NDA 8-851         NDK Fluoride Dentifrice     NDK Co., c/o J.W. Emmer/
                   (sodium                     Kenneth Emmer, 215
                   monofluorophosphate)        Genevieve Dr., Lafayette,
                                               LA 70503
------------------------------------------------------------------------
NDA 9-395         Paskalium (potassium        Glenwood, 111 Cedar Lane,
                   aminosalicylate)            Englewood, NJ 07631
------------------------------------------------------------------------
NDA 19-518        Extra Strength Aim (sodium  Chesebrough-Ponds USA Co.,
                   monofluorophosphate)        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 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 October 10, 2007.

    Dated: September 24, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-19865 Filed 10-9-07; 8:45 am]
BILLING CODE 4160-01-S