Eagle Pharmaceuticals announced that the FDA has accepted the NDA for Ryanodex (dantrolene sodium) and has granted a priority review classification for the treatment of malignant hyperthermia. Malignant hyperthermia can arise when patients come in contact during surgery with certain inhaled anesthetics or the muscle relaxant succinylcholine.
Compared to existing brands of dantrolene, the concentrated solution of Ryanodex allows significant reduction in time to reconstitute and administer the product (~1 minute). Each vial contains 250mg dantrolene that can be mixed with 5mL of sterile water, which further reduces infusion fluid volume.
Previously, Ryanodex has been granted Orphan Drug designation by the FDA. The company plans to commercialize Ryanodex after approval.
For more information call (201) 326-5300 or visit EagleUS.com.