[Federal Register Volume 61, Number 183 (Thursday, September 19, 1996)]
[Notices]
[Pages 49327-49329]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-24075]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0074]
Sperti Drug Products, Inc., et al.; Withdrawal of Approval of 40
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing 40 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: September 19, 1996.
FOR FURTHER INFORMATION CONTACT: Olivia A. Vieira, Center for Drug
Evaluation and Research (HFD-7), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-594-1046.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
[[Page 49328]]
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 March 12, 1996 (61 FR 9999), FDA offered
an opportunity for a hearing on a proposal to withdraw approval of 41
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 ConvaTec, P.O.
Box 147, St. Louis, MO 63166-0147, the firm that bought Calgon Vestal
Laboratories. ConvaTec has filed an annual report for 17-424, Septisol
Foam. Therefore, approval of this NDA is not being withdrawn.
The holders of the other 40 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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NDA no. Drug Applicant
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NDA 4-749....................... Bio-Dyne Ointment. Sperti Drug
Products, Inc.
NDA 8-532....................... Nicodrin Tablets.. Gold Leaf
Division, Ormont
Drug and Chemical
Co., Inc.
NDA 8-685....................... Puran Tablets..... Pure Laboratories,
Inc.
NDA 8-891....................... Buffered Parasal- Panray Division,
INH and INH 20 Ormont Drug and
Tablets. Chemical Co.,
Inc.
NDA 10-353...................... Parasal-Potassium Do.
Tablets.
NDA 11-902...................... Hematainer........ Courtland
Laboratories.
NDA 12-432...................... Meprobamate Gyma Labs.
Tablets.
NDA 12-435...................... Nitrofurantoin Do.
Tablets.
NDA 12-513...................... Petranquil Pharmaceutical
(Meprobamate) Philadelphia and
Tablets. Cosmetic Co.
NDA 12-866...................... Meprobamate Riverton
Tablets. Laboratories.
NDA 12-984...................... Secret Cream The Procter and
Deodorant. Gamble Co.
NDA 14-344...................... Meprobamate Bryant
Tablets. Pharmaceutical,
Corp.
NDA 14-364...................... Meprobamate Bates
Tablets. Laboratories,
Inc.
NDA 14-365...................... Meprobamate Philadelphia
Tablets. Laboratories,
Inc.
NDA 14-367...................... Meprobamate American
Tablets. Pharmaceutical
Co., Inc.
NDA 14-368...................... Meprobamate MK Laboratories,
Tablets. Inc.
NDA 14-509...................... Meprobamate Chase Chemical Co.
Tablets.
NDA 14-511...................... Meprobamate Davis-Edwards
Tablets. Pharmacal Corp.
NDA 14-600...................... Meprobamate Vitamix
Tablets. Pharmaceuticals,
Division of
Philadelphia
Pharmaceutical
and Cosmetic Co.
NDA 14-769...................... Meprobamate USV
Tablets. Pharmaceuticals.
NDA 14-862...................... Meprobamate Gold Leaf
Tablets. Pharmacal Co.,
Inc.
NDA 15-081...................... Meprobamate Kirkman
Tablets. Laboratories,
Inc.
NDA 15-170...................... Meprobamate Schlicksup Drug
Tablets. (FAS-CILE 400 and
FAC-CILE 200)
Co., Inc.
NDA 15-437...................... Meprobamate Phoenix
Tablets. Laboratories,
Inc.
NDA 16-051...................... Meprobamate Lit Drug Co.
Tablets.
NDA 16-068...................... Meprobamate Leeds-Dixon
Tablets. Laboratories,
Inc.
NDA 16-107...................... Protran Rand Laboratories,
*COM001*(Meprobam Inc.
ate)Tablets.
NDA 16-254...................... Meprobamate Modern Drugs, Inc.
Tablets.
NDA 16-731...................... Cuticura Medicated Purex.
Soap.
NDA 17-240...................... Bio/Dopa Steri-Med.
(Levodopa)
Capsules.
NDA 17-343...................... Actin-N Sherwood Medical
NitrofurazoneTopi Co.
cal Dressing.
NDA 17-417...................... Westasept Topical West Chemical
Solution. Products, Inc.
NDA 17-418...................... Wescohex Emulsion. Do.
NDA 17-419...................... Wescohex Topical The Vitarine Co.,
Emulsion. Inc.
NDA 17-423...................... Septisol Solution. Calgon Vestal
Laboratories.
NDA 17-460...................... Septi-Soft Do.
Solution.
NDA 17-540...................... Heparin Sodium Dell Laboratories.
Injection.
NDA 17-544...................... Dancon The Wella Corp.
Antidandruff
Shampoo.
NDA 17-580...................... Dancon Do.
Antidandruff
Shampoo.
NDA 18-363...................... Hexascrub Sponge.. Professional
Disposables,
Inc., Division of
Nice-Pak
Products, Inc.
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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, under this finding, approval of the
NDA's listed above, and all amendments and supplements thereto, is
hereby withdrawn, effective September 19, 1996.
[[Page 49329]]
Dated: August 28, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-24075 Filed 9-18-96; 8:45 am]
BILLING CODE 4160-01-F