Posted by Michael Wonder on 01 Sep 2018
FDA issues a complete response letter for new drug application for dasatroline for the treatment of ADHD
31 August 2018 - Sunovion Pharmaceuticals today announced that the U.S. FDA issued a complete response letter for the new drug application for dasotraline, a novel dual-acting dopamine and norepinephrine re-uptake inhibitor, for the treatment of attention-deficit hyperactivity disorder.
Upon completion of their review, the FDA determined that they cannot approve the dasotraline NDA for the treatment of ADHD in its current form. The FDA indicated that additional clinical data are needed to further evaluate the efficacy and tolerability of dasotraline for the treatment of ADHD.
Sunovion plans to meet with the FDA to discuss their comments and determine next steps.
