Watson seeks FDA approval for generic Vyvanse
PARSIPPANY, N.J. — Watson Pharmaceuticals has filed with the Food and Drug Administration for regulatory approval for a drug to treat attention deficit hyperactivity disorder, the company said Thursday.
Watson said it submitted its application for lisdexamfetamine dimesylate capsules, a generic version of Shire’s Vyvanse.
Shire has filed a patent infringement suit against Watson in the U.S. District Court for the Central District of California in an attempt to prevent Watson from marketing its version of the drug. Under laws governing generic drugs, the FDA can’t approve Watson’s generic version of Vyvanse until August 2014 or until the companies resolve the matter before the court.