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ViroPharma Announces Approval of Modernized Labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules
Date:12/14/2011

Parallel efforts regarding generic vancomycin capsules include ViroPharma's 2006 citizen petition, which has yet to be answered by FDA. Some recent issues raised in the petition include:

  • The work of Omar Vesga, M.D., of the Section of Infectious Diseases at University of Antioquia Medical School and Hospital Universitario San Vicente de Paul in Medellin, Colombia, substantiating the concerns of infectious disease experts that generic vancomycin capsules should not be approved without demonstrating in vivo efficacy.   Vesga showed generic intravenous vancomycin products, despite meeting all standard tests of generic equivalence, nonetheless fail in vivo (Generic Vancomycin Products Fail In Vivo despite Being Pharmaceutical Equivalents of the Innovator; Omar Vesga, et al.; Antimicrob. Agents Chemother. August 2010 vol. 54 no. 8 3271-3279).  This demonstration of generic inequivalence with the simple IV formulations of vancomycin supports the need to require that the more complicated generic vancomycin capsules demonstrate in vivo efficacy.
  • The United States Pharmacopeia (USP) agrees with ViroPharma that a modern assay to measure vancomycin capsule dissolution is needed: (http://www.usp.org/USPNF/notices/modernizationofMicrobialAssayProcedures.html).   ViroPharma has explained how without such an assay, FDA's proposed in vitro bioequivalence method for generic vancomycin capsules is unworkable, thus preventing the approval of generic vancomycin capsules.
  • FDA Advisory Committee experts emphasized the need for particularly rigorous inspections and cGMP compliance for generic vancomycin capsules approved via FDA's in vitro method. (ViroPharma Incorporated Letter to FDA in re: August 4 meeting of FDA Advisory Committee, Docket No. FDA-2009-N-0664-0047 (Oct 6, 2009)). Vesga's
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SOURCE ViroPharma Incorporated
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