Eagle Pharmaceuticals announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension, an antidote for the management of malignant hyperthermia (MH), along with the appropriate supportive measures.
Compared to existing brands of dantrolene, the concentrated solution of Ryanodex allows significant reduction in time to reconstitution and administration of the product (~1 minute). Each vial contains 250mg dantrolene that can be mixed with 5mL of sterile water, which further reduces infusion fluid volume.
Ryanodex will be supplied in 250mg/5mL single-use vials and will be available in August 2014.
For more information call (201) 326-530 or visit EagleUS.com.