Eagle Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Fast Track designation to Ryanodex (dantrolene sodium) injectable suspension for the treatment of exertional heat stroke (EHS).
EHS is a rare, sudden and unpredictable disorder that may result in severe multi-organ dysfunction and death. It is more commonly seen in young athletes undergoing exertional physical activity in hot temperatures, but also observed in construction workers, firefighters, military personnel, and farmers. EHS constitutes a medical emergency, however, no FDA-approved treatment currently exists.
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Ryanodex, a skeletal muscle relaxant, is currently indicated for the treatment of malignant hyperthermia (MH) in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
For more information call (201) 326-5300 or visit Eagleus.com