www.fdanews.com/articles/202185-supernus-earns-fda-approval-for-adhd-drug
Supernus Earns FDA Approval for ADHD Drug
April 6, 2021
Supernus Pharmaceuticals’ Qelbree (viloxazine) has secured FDA approval for treating attention-deficit hyperactivity disorder (ADHD) in children six to 17 years old via an extended release capsule.
The approval was supported by positive results from four phase 3 clinical trials that enrolled more than 1,000 patients, the drugmaker said.
The Rockville, Md., company also plans to submit a supplemental New Drug Application later this year, seeking approval for the drug for the treatment of adults.