FDA reviews sNDA of Vyvanse (Shire) as maintenenace treatment for young patients with ADHD

The FDA has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules, from Shire, as a maintenance treatment in children and adolescents ages 6 to 17 years with Attention-Deficit/Hyperactivity Disorder (ADHD). This application is based on results of a Phase IIIb, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of efficacy and safety of Vyvanse. This study was also included in the European Marketing Authorization Application submission package for approval of lisdexamfetamine dimesylate in Europe. Vyvanse is a prescription medication currently approved in the US for the treatment of ADHD in patients ages 6 to 17 and adults as part of a total treatment plan. Vyvanse is also approved in the US as a maintenance treatment for adults with ADHD.