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Home » Eagle draws CRL for new Ryanodex indication: heat stroke
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Eagle draws CRL for new Ryanodex indication: heat stroke

Aug. 10, 2020
By Michael Fitzhugh
Nearly three years after an FDA rejection of Eagle Pharmaceuticals Inc.'s initial effort to add exertional heat stroke (EHS) to the list of approved indications for Ryanodex (dantrolene sodium), its efforts have again been met with a complete response letter. The calcium channel modulator is already approved for the treatment of malignant hyperthermia (MH), but Eagle said it has decided to drop further pursuit of EHS.
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