FDA accepts Shire's sNDA for Vyvanse as maintenance treatment

Ireland-headquartered drugmaker Shire (LSE: SHP) that the US Food and Drug Administration has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) capsules, (CII).

Shire is seeking approval of Vyvanse as a maintenance treatment in children and adolescents ages 6 to 17 years with attention-deficit hyperactivity disorder (ADHD). There are currently no stimulants approved for maintenance treatment in children and adolescents ages 6 to 17 years with ADHD. The FDA has issued a Prescription Drug User Fee Act (PDUFA) action date of April 29, 2013.

"Shire is committed to furthering knowledge about ADHD and the ways in which this disorder can be treated," said Jeffrey Jonas, senior vice president of R&D for Shire's Specialty Pharmaceuticals and Regenerative Medicine Businesses. "This filing is important because only minimal data exist in children and adolescents assessing the maintenance of efficacy with a stimulant medication versus a placebo," he added.