Dasotraline FDA Approval Status

Last updated by Judith Stewart, BPharm on May 21, 2020.

FDA Approved: No
Generic name: dasotraline
Company: Sunovion Pharmaceuticals Inc.
Treatment for: ADHD, Eating Disorders

Dasotraline is a dual dopamine and norepinephrine reuptake inhibitor (DNRI) in development for the treatment of attention deficit hyperactivity disorder (ADHD) and binge eating disorder.

On May 13, 2020, Sunovion announced the withdrawal of the New Drug Applications (NDAs) for dasotraline, citing that further clinical studies would be needed to support regulatory approval.

Development timeline for dasotraline

Date	Article
May 13, 2020	Sunovion Discontinues Dasotraline Program
Jul 30, 2019	Sunovion Announces Acceptance by the U.S. FDA of the New Drug Application for Dasotraline for the Treatment of Adults with Moderate-to-Severe Binge Eating Disorder
Aug 31, 2018	FDA Issues a Complete Response Letter for New Drug Application for Dasotraline for the Treatment of ADHD
Jul 25, 2018	Sunovion Announces Positive Top-Line Results from Pivotal Study Evaluating Dasotraline in Adults with Binge Eating Disorder
Nov 10, 2017	Sunovion Announces FDA Acceptance for Review of New Drug Application for Dasotraline for the Treatment of ADHD
Aug 31, 2017	Sunovion Submits New Drug Application for Dasotraline to the FDA for the Treatment of Patients with ADHD

Further information

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