Home » FDA APPROVES EXPANDED INDICATION FOR ADDERALL XR
FDA APPROVES EXPANDED INDICATION FOR ADDERALL XR
July 27, 2005
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.
KEYWORDS Drug Pipeline Alert
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