FDA Approves Tris Pharma’s ADHD Drug for Children

Tris Pharma Inc. Oct. 20 said that the FDA has approved Dyanavel XR (amphetamine), extended-release oral suspension, CII, for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children six years of age and older.

With this approval, Dyanavel XR becomes the only once-daily, extended release amphetamine-based oral liquid approved for the treatment of ADHD in children, the company said.

Tris Pharma said it developed Dyanavel XR using its patented LiquiXR technology, a delivery system composed of both immediate-release and extended-release amphetamine. By using ion exchange polymeric chemistry, continuous release of amphetamine is achieved throughout the day, the company said.

“Amphetamines are ...