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.

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