Catalyst
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Eagle Pharmaceuticals Reports Positive Outcome From FDA Meeting For RYANODEX For Exertional Heat Stroke; Only Completion of Ongoing Animal Studies Required for NDA Submission
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Additional Information
The animal studies to support the NDA are currently underway. Upon successful completion of the animal studies, Eagle anticipates requesting priority review for its NDA submission. If approved, EHS would be the second indication for Ryanodex which is currently approved for the treatment of malignant hyperthermia (“MH") and for the prevention of MH in patients at high risk.
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Catalyst Date
Occurred on:
Aug 09, 2016
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Related Keywords
Ryanodex, Exertional Heat Stroke
