Shire submits Vyvanse sNDA for adult ADHD
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
After launching Vyvanse (lisdexamfetamine dimesylate) last month, Shire submits a supplemental claim for treatment of attention deficit/hyperactivity disorder in adults, the firm announces June 29. The sNDA will receive a standard review. FDA approved Vyvanse for treatment of ADHD in children ages 6-12 in February 2007 (1Pharmaceutical Approvals Monthly March 2007, In Brief), but as a controlled substance it could not be launched until final Drug Enforcement Administration scheduling. DEA announced its concurrence with FDA's recommendation for Schedule II status on May 3, with an effective date of June 4 (2Pharmaceutical Approvals Monthly June 2007, p. 23). The outcome of the sNDA review could affect Shire's plans for a long-acting adult-targeted version of Adderall XR, SPD465 (triple-beaded mixed amphetamine salts), which received an "approvable" letter in May...