FDA Rejects ViroPharma Testing Plea, OKs Generic Vancocin

Law360, New York (April 10, 2012, 6:22 PM EDT) -- ViroPharma Inc. said Tuesday that the U.S. Food and Drug Administration rejected its citizen petition challenging the approval of laboratory testing instead of human testing for generic versions of the gastrointestinal antibiotic Vancocin, as well as the company's bid for further market exclusivity for the drug.

The FDA also informed ViroPharma that it would approve three abbreviated new drug applications for a generic form of Vancocin. The agency released its decision Monday, and ViroPharma said Tuesday that it would lodge a complaint in Washington federal court...
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