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# NDA Accepted for Sunovian ADHD Drug
- URL: https://www.fdaweb.com/nda-accepted-for-sunovian-adhd-drug/
- Published: 2017-11-10T12:00:00.000Z
- Updated: 2026-09-14T23:01:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140104

FDA has accepted for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dual-acting dopamine and norepinephrine reuptake inhibitor for treating attention deficit hyperactivity disorder (ADHD) in children, adolescents and adults. The submission is based on data from multiple placebo-controlled safety and efficacy studies involving about 2,500 ADHD patients, according to the company. Dasotraline is a new chemical entity that has an extended half-life (47-77 hours) that “supports the potential for stable plasma concentrations yielding a continuous therapeutic effect over the 24-hour dosing interval,” it says. The drug is also being evaluated for treating binge eating disorder.