Posted by Michael Wonder on 13 May 2020
Vanda Pharmaceuticals announces agreement with FDA on resubmission of the application for Hetlioz for the treatment of patients with Smith-Magenis syndrome
13 May 2020 - Vanda Pharmaceuticals today announced that following the completion of a Type A meeting with the U.S. FDA on May 8, 2020, it has reached agreement with the FDA to resubmit its application for Hetlioz (tasimelteon) for the treatment of Smith-Magenis syndrome.
As previously disclosed, Vanda received a Refusal to File letter from the FDA on 12 March 2020. The Type A Meeting resolved the outstanding issues regarding the filing of the application.
Vanda plans to resubmit as soon as possible, seeking approval of the solid capsule formulation of Hetlioz for the treatment of adults with SMS, and the liquid formulation of Hetlioz for the treatment of children with Smith-Magenis syndrome.
