Actavis Fails to Win FDA Change in Vyvanse Exclusivity Decision

The FDA has affirmed five-year market exclusivity for Shire’s Vyvanse — a decision generic maker Actavis is challenging in a lawsuit against the agency. After reviewing statutory and regulatory standards and public comments, the agency determined exclusivity was properly granted, Shire says in a statement. The five-year exclusivity period for attention deficit hyperactivity disorder drug Vyvanse (lisdexamfetamine dimesylate) expires Feb. 23, 2012.
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