Posted by Michael Wonder on 10 Jan 2020
Eagle Pharmaceuticals resubmits NDA for Ryanodex for exertional heat stroke
9 January 2020 - Eagle Pharmaceuticals today announced that the Company has resubmitted its new drug application for Ryanodex (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke, in addition to body cooling, to the U.S. FDA.
Eagle believes that this submission addresses the complete response letter received in July 2017.
A Prescription Drug User Fee Act date of six months is anticipated for this class of resubmission.
