[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
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
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.
------------------------------------------------------------------------

    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