FDA APPROVES EXPANDED INDICATION FOR ADDERALL XR

The FDA has approved an expanded indication for Shire Pharmaceuticals' Adderall XR (amphetamine aspartate/dextroamphetamine saccharate), clearing the drug as a once-daily treatment for adolescents aged 13 to 17 with attention-deficit/hyperactivity disorder (ADHD). Adderall XR was already approved in the U.S. to treat ADHD in children aged 6 to 12 years and adults 18 years and older. The FDA approved the new indication based on a randomized, double-blind, placebo-controlled clinical trial that showed Adderall XR was significantly more effective than placebo in the treatment of ADHD symptoms in adolescents.