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# Eagle Pharma Files NDA for Ryanodex for Heat Stroke
- URL: https://www.fdaweb.com/eagle-pharma-files-nda-for-ryanodex-for-heat-stroke/
- Published: 2017-01-23T12:00:00.000Z
- Updated: 2026-09-14T22:02:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137798

Eagle Pharmaceuticals has submitted a 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke (EHS). The company has requested a priority review and, if granted, a user fee target date is expected in July. “Our innovative formulation of dantrolene sodium has unique properties that may allow Eagle’s low-volume high-concentration Ryanodex formulation, with its simple, rapid reconstitution and fast administration to be a potentially suitable therapy for the treatment of EHS in emergency settings,” the company says. EHS is a rare, sudden, and unpredictable medical condition characterized by severe hyperthermia and neurological dysfunction.