Approval granted for new Focalin XR labeling

May 30, 2006

Results of two studies in patients aged six to 12 years have ledNovartis to update the labeling of dexmethylphenidate HCl (FocalinXR) extended-release capsules. Significant improvements in ADHDsymptoms were observed at every hour up to 12 hours afteradministration of 20 mg of the drug compared with placebo.

Results of two studies in patients aged six to 12 years have led Novartis to update the labeling of dexmethylphenidate HCl (Focalin XR) extended-release capsules. Significant improvements in ADHD symptoms were observed at every hour up to 12 hours after administration of 20 mg of the drug compared with placebo. According to the company, these results show that Focalin XR has a rapid onset of action and will continue to work throughout the entire school day and beyond. Focalin XR is approved for the treatment of ADHD in children aged six years and older, adolescents, and adults.

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