Shire announced that the FDA has accepted the filing for review of a supplemental New Drug Application (sNDA) for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), seeking approval as a maintenance treatment in children and adolescents aged 6–17 years with Attention-Deficit/Hyperactivity Disorder (ADHD).
Shire is seeking approval based on the results of a clinical study (SPD489-326), a Phase 3b, randomized withdrawal, multicenter, extension study to evaluate the long-term maintenance of efficacy and safety of Vyvanse.
Vyvanse (lisdexamfetamine dimesylate) is a Schedule II controlled substance indicated for the treatment of ADHD in patients aged ≥6 as part of a total treatment plan that may include other measures (psychological, educational, social). Vyvanse is also approved as a maintenance treatment for adults with ADHD.
For more information call (800) 536-7878 or visit www.shire.com.