[Federal Register Volume 61, Number 80 (Wednesday, April 24, 1996)]
[Notices]
[Pages 18151-18152]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-10022]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 90N-0330]
The Kasdenol Corp., 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 three
new drug applications (NDA's) held by The Kasdenol Corp.; Lever
Brothers Co., Inc.; and United Pharmaceutical Inc. The basis for the
withdrawals is that the holders of the applications have repeatedly
failed to
[[Page 18152]]
file required annual reports on these NDA's.
EFFECTIVE DATE: May 24, 1996.
FOR FURTHER INFORMATION CONTACT: Lola E. Batson, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, -7500
Standish Pl., Rockville, MD 20855, 301-594-1038.
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).
In the Federal Register of July 13, 1990 (55 FR 28829), FDA offered
an opportunity for a hearing on a proposal to withdraw approval of five
NDA's because the firms had failed to submit the required annual
reports for these NDA's.
The agency had two responses to the notice of opportunity for
hearing: From Astra Pharmaceutical Products, Inc.; and from The Purdue
Frederick Co. Both responses indicated that the sponsors had previously
submitted letters requesting voluntary withdrawal of their NDA's (NDA
13-077 and NDA 11-160, respectively). In the Federal Register of March
27, 1996 (61 FR 13506 at 13507), FDA published a notice that withdrew
these applications.
The other three firms 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 9-394....................... Kasdenol Mouthwash The Kasdenol
or Gargle. Corp.,
Huntington, NY
11743.
NDA 10-094...................... Pepsodent Lever Brothers
Antiseptic Co., Inc., 390
Mouthwash. Park Ave., New
York, NY 10022.
NDA 13-397...................... Ampar SRC......... United
Pharmaceutical
Inc., 1500 North
Wilmut, Tucson,
AZ 85712.
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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, pursuant to this finding, approval
of the NDA's listed above, and all amendments and supplements thereto,
is hereby withdrawn, effective May 24, 1996.
Dated: April 9, 1996.
Murray M. Lumpkin,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. 96-10022 Filed 4-23-96; 8:45 am]
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