[Federal Register Volume 62, Number 132 (Thursday, July 10, 1997)]
[Notices]
[Pages 37063-37064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-17977]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 97N-0263]
Global Pharmaceutical Corp. et al.; Proposal to Withdraw Approval
of Four 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 for a hearing on the agency's proposal to withdraw approval
of four new drug applications (NDA's). 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 August 11, 1997; data
and information in support of the hearing request are due by September
8, 1997.
ADDRESSES: Requests for a hearing, supporting data, and other comments
should be identified with Docket No. 97N-0263 and submitted to the
Dockets Management Branch (HFA-305), Food and Drug Administration,
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, 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 or antibiotic 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 NDA's listed in the table below 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
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NDA 9-273....................... Rauwolfia Global
Serpentina Pharmaceutical
Tablets, 50 Corp., Castor and
milligrams (mg) Kensington Aves.,
and 100 mg. Philadelphia, PA
19124-5694.
NDA 11-623...................... Mucilose Super European Research
Powder. Associates, Ltd.,
Pailinakis Bldg.,
Elisabeth Ave.,
P.O. Box N3334,
Nassau, N.P.,
Bahamas.
NDA 12-748...................... Duotrate Jones Medical
(pentaerythritol Industries, Inc.,
tetranitrate) 1945 Craig Rd.,
Capsules, 45 mg. St. Louis, MO
63146.
NDA 16-470...................... Duotrate Do.
(pentaerythritol
tetranitrate)
Capsules, 30 mg.
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The last two products listed, NDA's 12-748 and 16-470, were named
in a notice of opportunity for hearing published in the Federal
Register of October 14, 1984 (49 FR 40213), under Docket No. 87N-0262,
proposing to withdraw the applications, along with other applicants'
products, because they lack substantial evidence of effectiveness. In
response to that notice, hearings were requested and a hearing was
granted (52 FR 32170, August 26, 1987); Jones Medical, the successor in
interest to NDA's 12-748 and 16-470, filed a Notice of Participation;
on May 10, 1989, the Administrative Law Judge issued his Initial
Decision, ordering that NDA's 17-748 and 16-740, and others, be
withdrawn; Jones Medical, as well as two other parties, appealed that
decision to the Commissioner of Food and Drugs (the Commissioner). If a
final order on NDA's 12-748 and 16-470 is issued under the present
matter for failing to file required annual reports, the appeal by Jones
Medical in Docket No. 87N-0262 will be regarded as withdrawn.
Therefore, notice is given to the holders of the NDA's 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 NDA's 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 above 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 August 11, 1997, a written notice of participation and request
for a hearing, and (2) on or before September 8, 1997, the data,
information, and analyses
[[Page 37064]]
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 hearing, notice of
participation, and request for 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 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 new drug application 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 hearing is not made in the required format or with the
required reports, 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 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: June 19, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-17977 Filed 7-9-97; 8:45 am]
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