FDA Approves Focalin XR to Treat ADHD in Adults, Adolescents and Children

Focalin XR (dexmethylphenidate HCl), developed jointly by Novartis Pharmaceuticals and Celgene, has been approved by the FDA as a treatment for attention-deficit/hyperactivity disorder (ADHD) in adults, adolescents and children.

The approval was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents and children diagnosed with ADHD.