Eagle Pharmaceuticals announced that the U.S. Food and Drug Administration has granted Fast Track designation to its RYANODEX (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke.
The FDA’s Fast Track program facilitates the development and review of drugs intended to treat serious conditions and address an unmet medical need.
A drug development program with Fast Track designation is afforded greater access to the FDA for the purpose of expediting the drug’s development, review and potential approval to get important new drugs to the patient earlier.
EHS is a leading cause of death in young athletes and non-combat related fatalities in the military.