[Federal Register Volume 72, Number 124 (Thursday, June 28, 2007)]
[Notices]
[Pages 35498-35499]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-12494]



[[Page 35498]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0246]


Menley & James Laboratories, Inc. et al.; Proposal to Withdraw 
Approval of Six New Drug Applications; Opportunity for a Hearing

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity to request a hearing on the agency's proposal to withdraw 
approval of six new drug applications (NDAs) from multiple sponsors. 
The basis for the proposal is that the sponsors have repeatedly failed 
to file required annual reports for these applications.

DATES: Submit written requests for a hearing by July 30, 2007; submit 
data and information in support of the hearing request by August 27, 
2007.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
are to be identified with Docket No. 2007N-0246 and submitted to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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). The holders of the approved applications 
listed in the following table have failed to submit the required annual 
reports and have not responded to the agency's request by certified 
mail for submission of the reports.

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

    Therefore, notice is given to the holders of the approved 
applications listed in the table and to all other interested persons 
that the Director of the Center for Drug Evaluation and Research 
proposes to issue an order under section 505(e) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(e)) withdrawing 
approval of the applications and all amendments and supplements thereto 
on the ground that the applicants have failed to submit reports 
required under Sec.  314.81.
    In accordance with section 505 of the act and 21 CFR part 314, the 
applicants are hereby provided an opportunity for a hearing to show why 
the applications listed previously should not be withdrawn and an 
opportunity to raise, for administrative determination, all issues 
relating to the legal status of the drug products covered by these 
applications.
    An applicant who decides to seek a hearing shall file the 
following: (1) A written notice of participation and request for a 
hearing (see DATES), and (2) the data, information, and analyses relied 
on to demonstrate that there is a genuine and substantial issue of fact 
that requires a hearing (see DATES). Any other interested person may 
also submit comments on this notice. The procedures and requirements 
governing this notice of opportunity for a hearing, notice of 
participation and request for a hearing, information and analyses to 
justify a hearing, other comments, and a grant or denial of a hearing 
are contained in Sec.  314.200 and 21 CFR part 12.
    The failure of an applicant to file a timely written notice of 
participation and request for a hearing, as required by Sec.  314.200, 
constitutes an election by that applicant not to avail itself of the 
opportunity for a hearing concerning the proposal to withdraw approval 
of the applications and constitutes a waiver of any contentions 
concerning the legal status of the drug products. FDA will then 
withdraw approval of the applications and the drug products may not 
thereafter lawfully be marketed, and FDA will begin appropriate 
regulatory action to remove the products from the market. Any new drug 
product marketed without an approved NDA is subject to regulatory 
action at any time.
    A request for a hearing may not rest upon mere allegations or 
denials, but must present specific facts showing that there is a 
genuine and substantial issue of fact that requires a hearing. Reports 
submitted to remedy the deficiencies must be complete in all respects 
in accordance with Sec.  314.81. If the submission is not complete or 
if a request for a hearing is not made in the required format or with 
the required reports, the Commissioner of Food and Drugs (the 
Commissioner) will enter summary judgment against the person who 
requests the hearing, making findings and conclusions, and denying a 
hearing.
    All submissions under this notice of opportunity for a hearing must 
be filed in four copies. Except for data and information prohibited 
from public disclosure under section 301 of the act (21 U.S.C. 331(j)) 
or 18 U.S.C. 1905, the submissions may be seen in the Division of 
Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday 
through Friday.
    This notice is issued under section 505 of the act and under 
authority delegated to the Director, Center for

[[Page 35499]]

Drug Evaluation and Research, by the Commissioner.

    Dated: June 11, 2007.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E7-12494 Filed 6-27-07; 8:45 am]
BILLING CODE 4160-01-S