FDA Affirms Exclusivity Period For Shire ADHD Drug

Law360, New York (October 27, 2009, 5:48 PM EDT) -- The U.S. Food and Drug Administration has affirmed its decision to grant a five-year new chemical entity exclusivity period to Shire PLC for its attention deficit hyperactivity disorder drug Vyvanse following a challenge lodged by a generic-drug maker, Shire said.

The FDA awarded NCE status to lisdexamfetamine dimesylate, marketed by Shire as Vyvanse, in February 2007, but the decision was challenged by generic pharmaceutical company Actavis Elizabeth LLC, which ultimately filed suit in the U.S. District Court for the District of Columbia to compel the agency...
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