FDA Rejects Favorable Vyvanse DEA Schedule: Time For Shire's 6 p.m. Theme
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA disagreed with New River Pharmaceuticals (now Shire) on the abuse liability of the d-amphetamine prodrug Vyvanse, forcing the sponsor to change its message from abuse protection to duration of effect - a secondary endpoint in pivotal trials that was not a notable issue in FDA's review of the pediatric attention deficit hyperactivity disorder NDA.