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US FDA Approves 30-Minute Onset of Action for Focalin(R) XR, Bringing Potential Benefits to ADHD Patients During Early Morning Period
Date:11/12/2008

Data indicate Focalin XR provides rapid and significant improvements in attention, behavior and academic productivity at 30 minutes post-dose Early onset of effect may help with school preparation in the morning as well as potentially improving academic productivity for children with ADHD

EAST HANOVER, N.J., Nov. 12 /PRNewswire/ -- The US Food and Drug Administration (FDA) has approved a 30-minute onset of action for Focalin(R) XR (dexmethylphenidate HCl) extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), bringing potential benefits for young patients and their families during the important morning period when they are preparing for school.

"The morning is a critical time for families," said Alice Mao, MD, Associate Professor of Psychiatry at the Baylor College of Medicine. "The early onset of Focalin XR provides symptom control which may help families and children living with ADHD get through their morning routine."

The new labeling is based on clinical study data. The most recent study, involving 86 children with ADHD between the ages of six and 12, showed that Focalin XR provided significant improvements at 30 minutes post-dose compared to placebo in measures of attention, deportment, and academic productivity.

ADHD affects approximately three to six percent of children in the United States, and its symptoms - inattention, hyperactivity and impulsivity - can significantly impact a child's ability to focus and behave in school.

A 2007 Harris survey of 1,001 caregivers of young ADHD patients revealed that caregivers were significantly more likely to report that their child's or adolescent's behavior was negatively affected in the morning compared to other periods through the day in 12 out of 16 common behaviors. These negative behaviors included lack of concentration, messiness, interrupting others, failure to complete tasks and speaking out of turn.

"The 30-minute ons
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SOURCE Novartis Pharmaceuticals Corporation
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