FDA Approves Ryanodex for Treating Hyperthermia Triggered by Anesthesia

Eagle Pharmaceuticals Inc. said July 23 it has received FDA approval for a drug to treat malignant hyperthermia.

The Woodcliff Lake, N.J.-based company said the Food and Drug Administration approval is for Ryanodex (dantrolene sodium) for injectable suspension.

Eagle said that malignant hyperthermia (MH) is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an orphan drug in August 2013, which meant the drug treats a rare condition. Eagle said it “has been informed by the FDA that it will learn over the next four to six weeks if ...