[Federal Register Volume 61, Number 49 (Tuesday, March 12, 1996)]
[Notices]
[Pages 9998-10000]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-5748]
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[[Page 9999]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0074]
Sperti Drug Products, Inc., et al.; Proposal To Withdraw Approval
of 41 New Drug Applications; Opportunity for Hearing
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is offering an
opportunity for a hearing on the agency's proposal to withdraw approval
of 41 new drug applications (NDA's). The basis for the proposal is that
the sponsors have repeatedly failed to file required annual reports for
these NDA's.
DATES: Written requests for a hearing are due by April 11, 1996; data
and information in support of the hearing request are due by May 13,
1996.
ADDRESSES: Requests for a hearing, supporting data, and other comments
should be identified with Docket No. 96N-0074, 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: 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). 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
requests by certified mail for submission of the reports.
------------------------------------------------------------------------
NDA no. Drug Applicant
------------------------------------------------------------------------
4-749........................... Bio-Dyne Ointment. Sperti Drug
Products, Inc.
8-532........................... Nicodrin Tablets.. Gold Leaf
Division, Ormont
Drug and Chemical
Co., Inc.
8-685........................... Puran Tablets..... Pure Laboratories
Inc.
8-891........................... Buffered Parasl- Panray Division,
INH & INH 20 Ormont Drug and
Tablets. Chemical Co.,
Inc.
10-353.......................... Parasal-Potassium Do.
Tablets.
11-902.......................... Hematainer........ Courtland
Laboratories.
12-432.......................... Meprobamate Gyma Labs.
Tablets.
12-435.......................... Nitrofurantoin Do.
Tablets.
12-513.......................... Pertranquil Philadelphia
(Meprobamate) Pharmaceutical
Tablets. and Cosmetic Co.
12-866.......................... Meprobamate Riverton
Tablets. Laboratories.
12-984.......................... Secret Cream The Procter and
Deodorant. Gamble Co.
14-344.......................... Meprobamate Bryant
Tablets. Pharmaceutical,
Corp.
14-364.......................... Meprobamate Bates
Tablets. Laboratories,
Inc.
14-365.......................... Meprobamate Philadelphia
Tablets. Laboratories,
Inc.
14-367.......................... Meprobamate American
Tablets. Pharmaceutical
Co. Inc.
14-368.......................... Meprobamate MK Laboratories,
Tablets. Inc.
14-509.......................... Meprobamate Chase Chemical Co.
Tablets.
14-511.......................... Meprobamate Davis-Edwards
Tablets. Pharmacal Corp.
14-600.......................... Meprobamate Vitamix
Tablets. Pharmaceuticals,
Division of
Philadelphia
Pharmaceutical
and Cosmetic Co.
14-769.......................... Meprobamate USV
Tablets. Pharmaceuticals.
14-862.......................... Meprobamate Gold Leaf
Tablets. Pharmacal Co.,
Inc.
15-081.......................... Meprobamate Kirkman
Tablets. Laboratories,
Inc.
15-170.......................... Meprobamate Schlicksup Drug
Tablets (FAS-CILE Co., Inc.
400 and FAC-CILE
200).
15-437.......................... Meprobamate Phoenix
Tablets. Laboratories,
Inc.
16-051.......................... Meprobamate Lit Drug Co.
Tablets.
16-068.......................... Meprobamate Leeds-Dixon
Tablets. Laboratories,
Inc.
16-107.......................... Protran Rand Laboratories,
(Meprobamate) Inc.
Tablets.
16-254.......................... Meprobamate Modern Drugs, Inc.
Tablets.
16-731.......................... Cuticura Medicated Purex.
Soap.
17-240.......................... Bio/Dopa Steri-Med.
(Levodopa)
Capsules.
17-343.......................... Actin-N Sherwood Medical
Nitrofurazone Co.
Topical Dressing.
17-417.......................... Westasept Topical West Chemical
Solution. Products, Inc.
17-418.......................... Wescohex Emulsion. Do.
17-419.......................... Wescohex Topical The Vitarine Co.,
Emulsion. Inc.
17-423.......................... Septisol Solution. Calgon Vestal
Laboratories.
17-424.......................... Septisol Foam..... Do.
17-460.......................... Septi-Soft Do.
Solution.
17-540.......................... Heparin Sodium Dell Laboratories.
Injection.
17-544.......................... Dancon The Wella Corp.
Antidandruff
Shampoo.
17-580.......................... Dancon Do.
Antidandruff
Shampoo.
18-363.......................... Hexascrub Sponge.. Professional
Disposables Inc.,
Division of Nice-
Pak Products,
Inc.
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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
[[Page 10000]]
all amendments and supplements thereto on the ground that the
applicants have failed to submit the 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 April 11, 1996, a written notice of participation and request
for a hearing, and (2) on or before May 13, 1996, 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 mew 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 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 pursuant to this notice of opportunity for a
hearing are to 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: February 28, 1996.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 96-5748 Filed 3-11-96; 8:45 am]
BILLING CODE 4160-01-F
