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ViroPharma Submits Comments on Vancocin(R) Draft Bioequivalence Guidance
Date:3/18/2009

o the point of ignoring the cautionary statements contained in the very authority cited by OGD as scientific support for its method, as well as the advice of its own experts.
  • When faced with a safety issue identified in Vancocin's labeling and by its own 2008 advisory committee - the potential for systemic absorption of the drug at toxic levels and the need for pharmacokinetic (PK) testing to address that safety issue - OGD again turned away from patients with CDI. Instead, they concluded that PK testing is unnecessary because the drug is not absorbed in healthy patients who are not infected with CDI.
  • By focusing exclusively on the lower GI tract, the December 2008 Draft Guidance fails to account for another indicated use of Vancocin - Staphylococcus aureus GI infections - which occur in both the upper and lower GI tract.
  • OGD's Q1Q2 sameness standard is flawed and incomplete. OGD acknowledges that inactive ingredients may affect product performance, and that the state of knowledge in this area is underdeveloped. However, OGD proposes without explanation that a Q1Q2 standard developed for oral solutions will nonetheless apply to Vancocin, an oral capsule product. Then, OGD backs off the sameness supposedly ensured by the Q1Q2 standard, and permits generic applicants to vary their inactive ingredients in the absence of any standards to evaluate the effect of such variations on the generic product's performance.
  • "OGD's extensive litany of errors and omissions not only required an equally extensive response, but should cause many to question, as we do, whether OGD has abrogated its decision-making role in bioequivalence method development for Vancocin," continued Doyle.

    While ViroPharma's comments note that numerous flaws prevent use of OGD's proposed new BE method for Vancocin, ViroPharma also believes that, even if the new method was valid, OGD's a
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    SOURCE ViroPharma Incorporated
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