Home » Actavis Fails to Win FDA Change in Vyvanse Exclusivity Decision
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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