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

Article Excerpt
EAST HANOVER, N.J., May 27 /PRNewswire/ -- Novartis Pharmaceuticals Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved Focalin XR(TM) (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults, adolescents and children.

"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."

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.

"We are pleased to introduce Focalin XR as a valuable treatment to help adults, adolescents and children effectively manage their symptoms of ADHD," said Paulo Costa, head of Pharma Americas and CEO, Novartis Pharmaceuticals Corporation. "Novartis has been a leader in helping ADHD patients since we first introduced Ritalin(R) in the 1960s. The addition of Focalin XR further emphasizes this commitment as...

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