SHIRE GETS ADDERALL APPROVAL

Shire Pharmaceuticals announced that the FDA has approved Adderall XR as a once-daily treatment for adolescents aged 13 to 17 with attention-deficit/hyperactivity disorder (ADHD). Since October 2001, Adderall XR has been approved for treatment in children aged 6 to 12 years and since August 2004 in adults 18 years and older.

The FDA based its approval on data that Shire provided in a supplement to its New Drug Application (sNDA). These data included the results of a pharmacokinetic study and a placebo-controlled, fixed-dose clinical trial of a range of doses of once-daily Adderall XR in adolescents with ADHD. In a randomized, double-blind, placebo-controlled clinical trial, Adderall XR was proven to be significantly more effective than placebo in the treatment of ADHD symptoms in adolescents.