28 December 2017 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently submitted new drug application for Epidiolex (cannabidiol), an investigational treatment for seizures associated with Lennox-Gastaut syndrome and Dravet syndrome, two rare and difficult to treat conditions of childhood-onset epilepsy.
The PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex application is 27 June 2018.