![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » 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.
Upcoming Events
-
21Oct