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news.Eagle Pharmaceuticals has received a Complete Response Letter from the US Food and Drug Administration (FDA) for its New Drug Application for RYANODEX (dantrolene sodium) for the treatment of exertional heat stroke (EHS), in conjunction with external cooling methods.
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In its letter to Eagle, the FDA has requested that the Company conduct an additional clinical trial for RYANODEX for Exertional Heat Stroke.
“We are reviewing our options and will evaluate the FDA’s response to chart a path forward for RYANODEX for this important indication and life-threatening condition,” said Scott Tarriff, Chief Executive Officer of Eagle.
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.