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Article: FDA Grants Approval to Market FOCALIN XR(TM) for the Treatment of ADHD in Adults, Adolescents and Children.
- Article from:
- PR Newswire
- Article date:
- May 27, 2005
CopyrightCOPYRIGHT 2005 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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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 ...