ARTICLE | Company News
Shire, Actavis neurology news
November 15, 2010 8:00 AM UTC
The U.S. Court of Appeals for the District of Columbia Circuit upheld FDA's granting of five years of new chemical entity (NCE) exclusivity for ADHD drug Vyvanse lisdexamfetamine from Shire. The court affirmed a decision from the U.S. District Court for the District of Columbia, which ruled in March that FDA reasonably interpreted the Food, Drug and Cosmetic Act in assigning NCE exclusivity to Vyvanse, and was correct in refusing to file an ANDA for a generic version of the drug from Actavis. The exclusivity period for Vyvanse expires on Feb. 23, 2012. At Sept. 30, Shire reported nine-month revenue of $453.6 million for Vyvanse. ...