Novartis Pharma AG was granted US FDA approval for Focalin XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children, announced by Celgene Corporation, partner of Novartis in the development and commercialization of Focalin XR.

The approval of Focalin XR for the treatment of ADHD was based on efficacy and safety data from clinical trials involving approximately 320 adults, adolescents and children diagnosed with ADHD.

"Focalin XR provides a new treatment option for adults, adolescents and children to address the many difficult symptoms of ADHD," Thomas Spencer, Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Paediatric Psychopharmacology Research Program at Massachusetts General Hospital said adding, "Focalin XR provides patients with a treatment that starts working quickly to alleviate symptoms with the advantage of a once-daily dose that lasts throughout the entire school or work day."

In adults and children, the core symptoms of ADHD are inattention, impulsivity and hyperactivity; however, in adults symptoms of hyperactivity often subside with maturity or may manifest differently. ADHD is one of the most common psychiatric disorders of childhood and is estimated to affect five to seven percent of children. Many children with ADHD will continue to experience symptoms into adulthood. ADHD is estimated to affect approximately four percent of the adult population.