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Novartis Pharma says FDA approves 30-Minute Onset of Action for Focalin XR for treatment of Attention Deficit/Hyperactivity - Quick Facts

Novartis Pharmaceuticals Corp., an affiliate of Novartis AG (NVS), announced that the US Food and Drug Administration approved a 30-minute onset of action for Focalin XR extended-release capsules for the treatment of Attention Deficit/Hyperactivity Disorder, or ADHD. The company noted that this brings potential benefits for young patients and their families during the important morning period when they are preparing for school.

ADHD affects approximately 3% to 6% of children in the United States, and its symptoms, which include inattention, hyperactivity and impulsivity, can significantly impact a child's ability to focus and behave in school.

The company said that 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.

Celgene Corp. (CELG) of Summit, New Jersey granted Novartis Pharma AG an exclusive worldwide license covering its intellectual property rights associated with Focalin XR.

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