Ryanodex filed at FDA for Malignant Hyperthermia - Eagle Pharma

Eagle Pharmaceuticals, Inc. has announced that the FDA has accepted the company's New Drug Application for Ryanodex (dantrolene) and granted a priority review classification. The PDUFA date is July 22, 2014. In January 2014, Eagle filed its NDA with the FDA for the treatment of Malignant Hyperthermia. In February 2014, the FDA conditionally accepted Eagle's trade name Ryanodex. Ryanodex has previously been granted Orphan Drug designation and Eagle currently owns three U.S. patents covering the product. Eagle intends to commercialize Ryanodex itself after approval and will retain exclusive marketing rights in the U.S.

Each vial of Ryanodex is re constituted in less than a minute by the anaesthiologist in contrast to the need to mix and administer approximately 12 vials of currently marketed products.