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Dasotraline FDA Approval Status

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

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

Further information

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