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FDA Clears Celgene, Novartis’ Once-Daily ADHD Drug

FDA approval for Focalin XR was based on clinical trial results that showed adults responded well to the treatment for over six months, and that young children responded to the treatment in about an hour.Summit’s Celgene (Nasdaq:CELG) said Friday the U.S. Food and Drug Administration has approved Focalin XR extended-release capsules for the treatment of attention-deficit/hyperactivity disorder (ADHD) in adults, adolescents and children.

In a press release, Celgene said the FDA approval was based on clinical trial results that showed adults responded well to the treatment for over six months, and that young children responded to the treatment in about an hour.

ADHD is a neurobiologic disorder that interferes with an individual’s ability to regulate activity level and behavior and sustain focus in developmentally appropriate ways.

Celgene said Focalin XR is an advance in single-isomer technology, providing favorable tolerability and dosing flexibility at only half the dose. Focalin, the original version of the drug, has to be taken twice daily and has been approved for the treatment of ADHD in children and adolescents.

Celgene licensed the worldwide rights (excluding Canada) to Focalin and Focalin XR to Novartis Pharma in exchange for milestone payments and royalties.

At the close pf trading, Celgene’s shares were up $0.26 to $41.20.

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