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ARTICLE | Company News

Priority Review for Eagle's dantrolene

March 20, 2014 11:58 PM UTC

FDA accepted and granted Priority Review to an NDA from Eagle Pharmaceuticals Inc. (NASDAQ:EGRX) for Ryanodex dantrolene to treat malignant hyperthermia. The PDUFA date is July 22. Ryanodex is a lyophilized formulation of the muscle relaxant dantrolene, which reverses the signs of malignant hyperthermia. Eagle said Ryanodex can be reconstituted in less than one minute compared to the 15-20 minutes required for marketed formulations of dantrolene.

Malignant hyperthermia is a potentially fatal, rare, inherited disorder characterized by a rapid heart rate, high body temperature and blood pressure and increased acid levels. The disorder is usually associated with the administration of certain anesthetics or succinylcholine, which triggers increased levels of calcium in the skeletal muscle. ...