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FDA Grants Approval to Market FOCALIN XR(TM) for the Treatment of ADHD in Adults, Adolescents and Children.

Publication: PR Newswire
Publication Date: 27-MAY-05 		Format: Online - approximately 1035 words
Delivery: Immediate Online Access

Article Excerpt
SUMMIT, N.J., May 27 /PRNewswire-FirstCall/ -- Celgene Corporation announced that Novartis Pharma AG, its partner in the development and commercialization of FOCALIN XR, was granted U.S. Food and Drug Administration (FDA) approval for FOCALIN XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children. 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," said Thomas Spencer, M.D., Associate Professor of Psychiatry, Harvard Medical School and Assistant Director of the Pediatric Psychopharmacology Research Program at Massachusetts General Hospital. "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...

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