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# FDA Accepts sNDA for Adult ADHD Drug
- URL: https://www.fdaweb.com/fda-accepts-snda-for-adult-adhd-drug/
- Published: 2021-09-03T12:00:00.000Z
- Updated: 2026-09-14T17:13:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150078

FDA has accepted for review a Supernus Pharmaceuticals supplemental NDA for Qelbree (viloxazine extended-release capsules) for treating attention-deficit hyperactivity disorder (ADHD) in adult patients. The agency has set a user fee review action target date of 4/29/2022\. Qelbree was originally approved in April for treating ADHD in pediatric patients aged six to 17 years.

The submission is based on data from the company’s Phase 3 study of Qelbree in adults with ADHD that showed “statistical significance” compared to placebo as measured by the ADHD Investigator Symptom Rating Scale, according to the company.