[Federal Register Volume 63, Number 231 (Wednesday, December 2, 1998)]
[Notices]
[Pages 66549-66550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32069]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-1036]


Vale Chemical Co., Inc., et al.; Proposal to Withdraw Approval of 
13 New Drug Applications and 1 Abbreviated New Drug Application; 
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 for a hearing on the agency's proposal to withdraw approval 
of 13 new drug applications (NDA's) and 1 abbreviated new drug 
application (ANDA). The basis for the proposal is that the sponsors 
have repeatedly failed to file required annual reports for these 
applications.

DATES: Written requests for a hearing are due by January 4, 1999; data 
and information in support of the hearing request are due by February 
1, 1999.

ADDRESSES: Requests for a hearing, supporting data, and other comments 
should be identified with Docket No. 98N-1036 and submitted to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Olivia A. Pritzlaff, 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 applications listed in 
the following table have failed to submit the required

[[Page 66550]]

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 7-112..........................  Nisaval (pyrilamine maleate) 25        Vale Chemical Co., Inc., 1201
                                      milligram (mg) Tablets.                Liberty St., Allentown, PA 18102.
NDA 11-863.........................  Flavihist Cough Syrup................  Boyle & Co., 6330 Chalet Dr., Los
                                                                             Angeles, CA 90022.
NDA 50-042.........................  Potassium Penicillin G Diagnostic      Pfizer Inc., 235 East 42d St., New
                                      Sensitivity Powder, 20,000 units.      York, NY 10017-5755.
NDA 50-067.........................  Compocillin-VK Chewable Wafers.......  Abbott Laboratories, 100 Abbott Park
                                                                             Rd., Abbott Park, IL 60064.
NDA 50-088.........................  Unipen Injection.....................  Wyeth-Ayerst Laboratories, P.O. Box
                                                                             8299, Philadelphia, PA 19101-8299.
NDA 50-121.........................  Compocillin-VK Tablets...............  Abbott Laboratories.
NDA 50-122.........................  Compocillin-V Chewable Wafers........  Do.
NDA 50-129.........................  Pen-Vee Suspension and Drops.........  Wyeth-Ayerst Laboratories.
NDA 50-189.........................  Omnipen Tablets......................  Do.
NDA 50-197.........................  Unipen Injection.....................  Do.
NDA 50-305.........................  Unipen Capsules......................  Do.
NDA 50-319.........................  Omnipen Chewable Tablets.............  Do.
NDA 50-413.........................  Geopen Diagnostic Susceptibility       Pfizer Inc.
                                      Powder.
ANDA 87-387........................  Aminophylline Injection USP,25 mg/     Pharma-Serve, Inc., 218-20 98th
                                      milliliter.                            Ave., Queens Village, NY 11429.
----------------------------------------------------------------------------------------------------------------

    Therefore, notice is given to the holders of the 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 part 314 (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: (1) On or 
before January 4, 1999, a written notice of participation and request 
for a hearing, and (2) on or before February 1, 1999, the data, 
information, and analyses relied on to demonstrate that there is a 
genuine and substantial issue of fact that requires a hearing. 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 in 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 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 21 U.S.C. 331(j) or 18 U.S.C. 1905, the 
submissions may be seen in the Dockets Management Branch (address 
above) between 9 a.m. and 4 p.m., Monday through Friday. This notice is 
issued under the Federal Food, Drug, and Cosmetic Act (sec. 505 (21 
U.S.C. 355)) and under authority delegated to the Director, Center for 
Drug Evaluation and Research (21 CFR 5.82).

    Dated: November 12, 1998.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 98-32069 Filed 12-1-98; 8:45 am]
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