FDA Wrongly Approved Generic Vancocin, ViroPharma Argues

Law360, New York (July 23, 2012, 3:45 PM EDT) -- The U.S. Food and Drug Administration violated both the Federal Food, Drug and Cosmetic Act and its own regulations when it approved generic versions of the gastrointestinal antibiotic Vancocin, the drug's manufacturer, ViroPharma Inc., argued in a brief Friday.

The drugmaker, which wants a Washington federal judge to block the generic approvals, argued in a summary judgment motion that its exclusivity rights over Vancocin should have been extended until Dec. 15, 2014, after the FDA in December approved a supplemental new drug application for Vancocin that...
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