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Dasotraline 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.

Development Status and FDA Approval Process for dasotraline

DateArticle
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
Apr 21, 2017Sunovion Announces Positive Results from Pivotal Study Evaluating Novel Drug Candidate Dasotraline in Children with ADHD
Jan 14, 2017Sunovion Announces Pivotal Study Results for Novel Drug Candidate Dasotraline Demonstrating Significantly Improved Attention Deficit Hyperactivity Disorder Symptoms in Children Compared to Placebo
Jan 13, 2017Sunovion Announces Top-line Results from Studies Evaluating Dasotraline in Adults with Binge Eating Disorder and Attention Deficit Hyperactivity Disorder

Further information

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