[Federal Register Volume 62, Number 221 (Monday, November 17, 1997)]
[Notices]
[Pages 61338-61339]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30148]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. 97N-0263 and 87N-0262]
European Research Associates, Ltd. et al.; Withdrawal of Approval
of Three New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of three new drug applications (NDA's). The basis for the withdrawals
is that the holders of the applications have repeatedly failed to file
required annual reports on these NDA's.
EFFECTIVE DATE: November 17, 1997.
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 or antibiotics 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 July 10, 1997 (62 FR 37063), FDA offered
an opportunity for a hearing on a proposal to withdraw approval of four
NDA's because the firms had failed to submit the required annual
reports for these NDA's.
The agency received one request for a hearing from Global
Pharmaceutical Corp., Castor and Kensington Aves., Philadelphia, PA
19124-5694. Global has filed an annual report for NDA 9-273, Rauwolfia
Serpentina Tablets, 50 and 100 milligram (mg). Therefore, approval of
this NDA is not being withdrawn.
The holders of the other three applications did not respond to the
notice of opportunity for hearing. Failure to file a written notice of
participation and request for a hearing as required by 21 CFR 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 NDA's
listed in the table in this document.
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Application No. Drug Applicant
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NDA 11-623 Mucilose Super Powder European Research Associates, Ltd.,
Pailinakis Bldg., Elisabeth Ave., P.O. Box
N3334, Nassau, N.P., Bahamas.
NDA 12-748 Duotrate (pentaerythritol tetranitrate) Jones Medical Industries, Inc., 1945 Craig
Capsules, 45 mg Rd., St. Louis, MO 63146.
NDA 16-470 Duotrate (pentaerythritol tetranitrate) Do.
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), 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
[[Page 61339]]
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 12-748 and 16-470, and others, be
withdrawn; Jones Medical, as well as two other parties, appealed that
decision to the Commissioner. On the basis of the present withdrawal of
approval of NDA's 12-748 and 16-470 for failing to file required annual
reports, the appeal by Jones Medical in Docket No. 87N-0262 is regarded
as withdrawn.
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 of 21 CFR 5.82, finds that the holders of
the applications listed above have repeatedly failed to submit reports
required by Sec. 314.81. Therefore, under this finding, approval of the
NDA's listed above, and all amendments and supplements thereto, is
hereby withdrawn, effective November 17, 1997.
Dated: November 6, 1997.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 97-30148 Filed 11-14-97; 8:45 am]
BILLING CODE 4160-01-F
