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

regulations, labeling changes based on new clinical investigations that are essential to approval of the sNDA and to which the applicant has exclusive rights may be entitled to three years of exclusivity, and generic drug labeling cannot include information protected by such three-year exclusivity.  A generic may seek approval by omitting labeling protected by three-year exclusivity; however, if such omissions render the generic drug less safe or effective, it cannot be approved until the three-year exclusivity expires.

In keeping with FDA efforts to facilitate antibiotic approvals as well as preserve the safety and efficacy of current treatments, today's sNDA approval following ViroPharma's investment in the Genzyme data accomplishes an objective of the law to incent private industry to address a serious public health need - modernizing old antibiotic labeling.  The modernized label approved by the FDA contains important new information for prescribers and patients, including:

  • Clinical safety and efficacy data of Vancocin capsules, including efficacy data for the more lethal, epidemic BI/NAP1 strain;
  • An instruction to monitor renal function in all patients;
  • An instruction that elderly patients should not be prematurely discontinued from treatment, or switched to other therapies; and
  • A specific dosing regimen for CDAD.

ViroPharma believes that attempting to omit Vancocin labeling changes protected by exclusivity would render generic versions of Vancocin less safe and effective.  These and other issues regarding the modernized Vancocin labeling and its impact on generic vancomycin applications will be detailed in an upcoming filing to the Vancocin citizen petition.  Ultimately, the decision on a grant of three-year exclusivity and its effect on generic vancomycin capsule approvals resides with the FDA.

Citizen Petition Update


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SOURCE ViroPharma Incorporated
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