Posted by Michael Wonder on 03 Aug 2020
FDA accepts and grants priority review of Vanda's applications for Hetlioz (tasimelteon) in the treatment of Smith-Magenis syndrome
3 August 2020 - Vanda Pharmaceuticals today announced that the U.S. FDA has accepted for priority review Vanda's applications for Smith-Magenis syndrome.
The applications include a supplemental new drug application for Hetlioz capsules and a new drug application for the liquid formulation of Hetlioz for the treatment of adults and children, respectively, with Smith-Magenis syndrome.
The FDA has set 1 December 2020 as the target date for its decision under the Prescription Drug User Fee Act.
