[Federal Register Volume 79, Number 221 (Monday, November 17, 2014)]
[Notices]
[Pages 68454-68455]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-27039]


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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.; Withdrawal of Approval of 14 
New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 14 new drug applications (NDAs) from multiple holders of these 
applications. The basis for the withdrawals is that the holders of the 
applications have repeatedly failed to file required annual reports for 
the applications.

DATES: November 17, 2014.

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).
    In the Federal Register of November 6, 2013 (78 FR 66748), FDA 
published a notice offering an opportunity for a hearing (NOOH) on a 
proposal to withdraw approval of 14 NDAs because the firms had failed 
to submit the required annual reports for these applications. The 
holders of these applications did not respond to the NOOH. Failure to 
file a written notice of participation and request for hearing as 
required by Sec.  314.200 (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 14 applications listed in 
table 1 of this document.

     Table 1--Approved NDAs for Which Required Reports Have Not Been
                                Submitted
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        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           USV Pharmaceutical
                                 (inositol/vitamin    Corp., 500
                                 B12/racemethionine/  Virginia 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                 Parke-Davis, 201
                                 (corticotropin)      Tabor Rd., Morris
                                 Injection.           Plains, NJ 07950.
NDA 009515....................  Hyrye (riboflavin    S.F. Durst and Co.,
                                 5'-phosphate         Inc., 5317-21
                                 sodium) Injection.   North Third St.,
                                                      Philadelphia, PA
                                                      19120.
NDA 010415....................  Flamotide            Philadelphia
                                 (riboflavin 5'-      Ampoule
                                 phosphate sodium)    Laboratories, 400
                                 Injection.           Green St.,
                                                      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,
                                 Injection.           Inc., 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           Armour
                                 Synthetic            Pharmaceutical
                                 (seractide           Co., P.O. Box 511,
                                 acetate) Injection.  Kankakee, IL
                                                      60901.
NDA 018087....................  Thyrel TRH           Ferring
                                 (protirelin)         Pharmaceuticals,
                                 Injection.           Inc., 400 Rella
                                                      Blvd., suite 300,
                                                      Suffern, NY 10901.
------------------------------------------------------------------------

    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 delegated by the Commissioner, finds that 
the holders of the applications listed in this document have repeatedly 
failed to submit reports required by Sec.  314.81. In addition, under 
Sec.  314.200, we find that the holders of the applications have waived 
any contentions concerning the legal status of the drug products. 
Therefore, under these findings, approval of the applications listed in 
this document, and all amendments and supplements thereto, is hereby 
withdrawn, effective November 17, 2014.


[[Page 68455]]


    Dated: November 10, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-27039 Filed 11-14-14; 8:45 am]
BILLING CODE 4164-01-P