received approval for an extended-release version of a drug for attention-deficit/hyperactivity disorder, the companies announced Friday.
The Food and Drug Administration approved the once-daily drug, Focalin XR, for treating the condition in children and adults. The original version of the ADHD drug is taken twice daily.
The approval was based on efficacy and safety data from clinical trials involving 221 men and women with ADHD ages 18 to 60 and 103 ADHD patients ages 6 to 17 years.
ADHD occurs in children and adults, affecting behavior and focus and causing emotional and social disturbances. According to Novartis, Focalin, a stimulant, helps the brain control impulses and regulates behavior and attention.
Celgene shares were recently down 2 cents, to $40.92, and shares of Switzerland's Novartis were unchanged at $49.65.