FDA gives complete response to filing of Ryanodex (dantrolene sodium) for exertional heat stroke- Eagle Pharmaceuticals
Eagle Pharmaceuticals has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its 505(b)(2) New Drug Application for Ryanodex (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
In its letter to Eagle, the FDA has requested that the Company conduct an additional clinical trial for Ryanodex for Exertional Heat Stroke. Ryanodex remains approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
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