Document headings vary by document type but may contain
                    the following: the agency or agencies that issued and signed a document
the number of the CFR title and the number of each part
                      the document amends, proposes to amend, or is directly
                      related to
the agency docket number / agency internal file number
the RIN which identifies each regulatory action listed in
                      the Unified Agenda of Federal Regulatory and Deregulatory
                      Actions See the
                    Document Drafting Handbook
                    for more details.
 Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2013-N-1285]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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 § 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 § 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
Application No.
Drug
ApplicantNDA 004979
Multi-Vitamin Tablets
Smith Miller and Patch Inc., P.O. Box 367, San German, PR 00753.NDA 008176
Methostan (methandriol) Tablets
Do.NDA 008326
Methischol (inositol/vitamin B12/racemethionine/choline chloride) Injection
USV Pharmaceutical Corp., 500 Virginia Dr., Fort Washington, PA 19034-2779.NDA 008362
Corticotropin Injection
Vitarine Pharmaceuticals Inc., 227-15 North Conduit Ave., Springfield Gardens, NY 11413.NDA 009346
ACTH (corticotropin) Injection
Parke-Davis, 201 Tabor Rd., Morris Plains, NJ 07950.NDA 009515
Hyrye (riboflavin 5′-phosphate sodium) Injection
S.F. Durst and Co., Inc., 5317-21 North Third St., Philadelphia, PA 19120.NDA 010415
Flamotide (riboflavin 5′-phosphate sodium) Injection
Philadelphia Ampoule Laboratories, 400 Green St., Philadelphia, PA 19123.NDA 010565
Duracton (corticotropin) Injection
Nordic Biochemicals Inc., 45 Bay State Rd., Boston, MA 02215.NDA 010791
Rubivite (cyanocobalamin) Injection
Bel Mar Laboratories, Inc., 6-10 Nassau Ave., Inwood, NY 11696.NDA 010831
Corticotropin Injection
Organics/LaGrange, Inc., 1935 Techny Rd., suite 14, Northbrook, IL 60062.NDA 011015
RU-B-12-1000 (cyanocobalamin) Injection
Dow Pharmaceutical Corp., 9550 North Zionsville Rd., Indianapolis, IN 46268.NDA 011578
Efacin (niacin) Tablet
Person and Covey, Inc., 616 Allen Ave., Glendale, CA 91201.NDA 017861
Acthar Gel Synthetic (seractide acetate) Injection
Armour Pharmaceutical Co., P.O. Box 511, Kankakee, IL 60901.NDA 018087
Thyrel TRH (protirelin) Injection
Ferring Pharmaceuticals, 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 § 314.81. In addition, under § 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. 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