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Eagle gets complete response letter from FDA on exertional heat stroke drug RYANODEX

05:55 EDT 27 Jul 2017 | Pharmaceutical Business Review

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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