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

EXTON, Pa., Dec. 14, 2011 /PRNewswire/ -- ViroPharma Incorporated (Nasdaq: VPHM) today announced the modernization of labeling for Vancocin® (vancomycin hydrochloride, USP) Capsules made effective through the U.S. Food and Drug Administration's (FDA) approval of a supplemental new drug application (sNDA).  The company also provided updates on ViroPharma's ongoing citizen petition and litigation with the FDA regarding Vancocin.

Vancocin Labeling Changes

Through the sNDA approval, Vancocin's label for the first time includes clinical safety and efficacy data for Vancocin in treating currently circulating strains of Clostridium difficile, including the BI/NAP1 strain.  Vancocin's labeling now includes important safety and efficacy data from 260 patients with C. difficile associated diarrhea (CDAD) treated with Vancocin in two pivotal studies of Genzyme Corporation's investigational drug, tolevamer.  The Vancocin arm of the trials provides important information to help ensure appropriate use of Vancocin. ViroPharma purchased exclusive rights to the two studies from Genzyme for which it will pay Genzyme royalties of 10 percent, 10 percent and 16 percent on net sales of Vancocin for the three year period following the approval of the sNDA. 

"This new label provides physicians a better understanding about how to treat and monitor patients suffering from the serious and often life threatening infections that require oral Vancocin therapy," said Vincent Milano, ViroPharma's president and chief executive officer.

Exclusivity Incentives for Antibiotic Treatments

As a result of today's sNDA approval, ViroPharma believes Vancocin meets the requirements for, and thus has, three years of exclusivity, and that generic vancomycin capsules will not be approved during this period.  Under FDA's
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SOURCE ViroPharma Incorporated
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