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Smith Miller and Patch, Inc. et al.; Withdrawal of Approval of 14 New Drug Applications

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Food and Drug Administration, HHS.




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.


November 17, 2014.

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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.

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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.DrugApplicant
NDA 004979Multi-Vitamin TabletsSmith Miller and Patch Inc., P.O. Box 367, San German, PR 00753.
NDA 008176Methostan (methandriol) TabletsDo.
NDA 008326Methischol (inositol/vitamin B12/racemethionine/choline chloride) InjectionUSV Pharmaceutical Corp., 500 Virginia Dr., Fort Washington, PA 19034-2779.
NDA 008362Corticotropin InjectionVitarine Pharmaceuticals Inc., 227-15 North Conduit Ave., Springfield Gardens, NY 11413.
NDA 009346ACTH (corticotropin) InjectionParke-Davis, 201 Tabor Rd., Morris Plains, NJ 07950.
NDA 009515Hyrye (riboflavin 5′-phosphate sodium) InjectionS.F. Durst and Co., Inc., 5317-21 North Third St., Philadelphia, PA 19120.
NDA 010415Flamotide (riboflavin 5′-phosphate sodium) InjectionPhiladelphia Ampoule Laboratories, 400 Green St., Philadelphia, PA 19123.
NDA 010565Duracton (corticotropin) InjectionNordic Biochemicals Inc., 45 Bay State Rd., Boston, MA 02215.
NDA 010791Rubivite (cyanocobalamin) InjectionBel Mar Laboratories, Inc., 6-10 Nassau Ave., Inwood, NY 11696.
NDA 010831Corticotropin InjectionOrganics/LaGrange, Inc., 1935 Techny Rd., suite 14, Northbrook, IL 60062.
NDA 011015RU-B-12-1000 (cyanocobalamin) InjectionDow Pharmaceutical Corp., 9550 North Zionsville Rd., Indianapolis, IN 46268.
NDA 011578Efacin (niacin) TabletPerson and Covey, Inc., 616 Allen Ave., Glendale, CA 91201.
NDA 017861Acthar Gel Synthetic (seractide acetate) InjectionArmour Pharmaceutical Co., P.O. Box 511, Kankakee, IL 60901.
NDA 018087Thyrel TRH (protirelin) InjectionFerring 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.

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Dated: November 10, 2014.

Leslie Kux,

Assistant Commissioner for Policy.

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[FR Doc. 2014-27039 Filed 11-14-14; 8:45 am]