Posted by Michael Wonder on 28 Mar 2017
FDA grants priority review for Eagle Pharmaceuticals’ Ryanodex NDA for the treatment of exertional heat stroke
27 March 2017 - Eagle Pharmaceuticals announced today that their 505(b)(2) new drug application for Ryanodex (dantrolene sodium) for the treatment of exertional heat stroke has been accepted for filing and granted a priority review designation by the U.S. FDA.
The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to complete its review within six months of the NDA submission; the PDUFA date for the application has been set for 23 July 2017.
