FDA OKs NDA For Eagle Pharma' Orphan Drug Ryanodex For Malignant Hyperthermia

(RTTNews) - Eagle Pharmaceuticals, Inc. (EGRX) said the United States Food and Drug Administration or FDA has accepted its New Drug Application for Ryanodex and granted a priority review classification. The PDUFA date is July 22, 2014.

Eagle filed its NDA with the FDA for the treatment of malignant hyperthermia in January 2014. The FDA, in February 2014, conditionally accepted Eagle's trade name Ryanodex. Ryanodex has earlier been granted Orphan Drug designation and Eagle currently owns three U.S. patents covering the product. Eagle plans to commercialize Ryanodex after approval and would retain exclusive marketing rights in the U.S.

Malignant Hyperthermia is a condition, which is triggered when genetically susceptible individuals come in contact during surgery with certain inhaled anesthetics or the muscle relaxant succinylcholine.