FDA approves Tris Pharma’s Dyanavel XR

MONMOUTH JUNCTION, N.J. — Tris Pharma on Tuesday announced that it had received approval from the Food and Drug Administration for its Dyanavel XR (amphetamine) extended-release oral suspension. Dyanavel is indicated as a once-daily treatment for attention deficit/hyperactivity disorder in children ages 6 and older.

“Dyanavel XR is the first and only once-daily, extended-release amphetamine oral suspension for the treatment of ADHD,” Tris’ chief medical officer Dr. Sally Berry said. “Amphetamines are well-established as effective treatment for ADHD.  Dyanavel  XR offers physicians a new pediatric-friendly dosing option that couples fast onset with a long duration of effect suitable for school-aged children.”

The drug is expected to be available in 2016, the company said.