[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66748-66750]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-26491]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1285]
Smith Miller and Patch Inc. et al.; Proposal to Withdraw Approval
of 14 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 to request a hearing on the Agency's proposal to withdraw
approval of 14 new drug applications (NDAs) from multiple sponsors. The
basis for the proposal is that the sponsors have repeatedly failed to
file required annual reports for these applications.
DATES: Submit written requests for a hearing by December 6, 2013;
submit data and information in support of the hearing request by
January 6, 2014.
ADDRESSES: Identify your requests for a hearing, supporting data, and
other comments with Docket No. FDA-2013-N-1285, and submit this
information to the Division of Dockets Management (HFA-305), Food and
Drug
[[Page 66749]]
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of approved applications to
market new 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 approved applications
listed in table 1 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.
Table 1--Approved NDAs for Which Required Reports Have Not Been Made
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Application No. Drug Applicant
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NDA 004979.................. Multi-Vitamin Smith Miller and
Tablets. Patch Inc., P.O.
Box 367, San
German, PR 00753.
NDA 008176.................. Methostan Do.
(methandriol)
Tablets.
NDA 008326.................. Methischol (inositol/ USV Pharmaceutical
vitamin B12/ Corp., 500 Virginia
racemethionine/ Dr., Fort
choline chloride) Washington, PA
Injection. 19034-2779.
NDA 008362.................. Corticotropin Vitarine
Injection. Pharmaceuticals
Inc., 227-15 North
Conduit Ave.,
Springfield
Gardens, NY 11413.
NDA 009346.................. ACTH (corticotropin) Parke-Davis, 201
Injection. Tabor Rd., Morris
Plains, NJ 07950.
NDA 009515.................. Hyrye (riboflavin 5'- S.F. Durst and Co.,
phosphate sodium) Inc., 5317-21 North
Injection. Third St.,
Philadelphia, PA
19120.
NDA 010415.................. Flamotide Philadelphia Ampoule
(riboflavin 5'- Laboratories, 400
phosphate sodium) Green St.,
Injection. Philadelphia, PA
19123.
NDA 010565.................. Duracton Nordic Biochemicals
(corticotropin) Inc., 45 Bay State
Injection. Rd., Boston, MA
02215.
NDA 010791.................. Rubivite Bel Mar
(cyanocobalamin) Laboratories, Inc.,
Injection. 6-10 Nassau Ave.,
Inwood, NY 11696.
NDA 010831.................. Corticotropin Organics/LaGrange,
Injection. Inc., 1935 Techny
Rd., Suite 14,
Northbrook, IL
60062.
NDA 011015.................. RU-B-12-1000 Dow Pharmaceutical
(cyanocobalamin) Corp., 9550 North
Injection. Zionsville Rd.,
Indianapolis, IN
46268.
NDA 011578.................. Efacin (niacin) Person and Covey,
Tablet. Inc., 616 Allen
Ave., Glendale, CA
91201.
NDA 017861.................. Acthar Gel Synthetic Armour
(seractide acetate) Pharmaceutical Co.,
Injection. P.O. Box 511,
Kankakee, IL 60901.
NDA 018087.................. Thyrel TRH Ferring
(protirelin) Pharmaceuticals,
Injection. Inc., 400 Rella
Blvd., Suite 300,
Suffern, NY 10901.
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Therefore, notice is given to the holders of the approved
applications listed in table 1 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 (FD&C Act) (21 U.S.C. 355(e)) withdrawing approval of the
applications 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 FD&C Act and part 314 (21 CFR
part 314), the applicants are hereby provided an opportunity for a
hearing to show why the applications listed previously 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 must file the following:
(1) A written notice of participation and request for a hearing (see
DATES) and (2) the data, information, and analyses relied on to
demonstrate that there is a genuine and substantial issue of fact that
requires a hearing (see DATES). 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 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 a 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 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 Division of Dockets Management (see
ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday, and will
be posted to the docket at http://www.regulations.gov.
This notice is issued under the Federal Food, Drug, and Cosmetic
Act (section 505 (21 U.S.C. 355)) and under authority delegated to the
Director,
[[Page 66750]]
Center for Drug Evaluation and Research, by the Commissioner of Food
and Drugs.
Dated: October 30, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-26491 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P