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# FDA Gives Priority Review for Eagle 505(b)(2) NDA
- URL: https://www.fdaweb.com/fda-gives-priority-review-for-eagle-505-b-2-nda/
- Published: 2017-03-27T12:00:00.000Z
- Updated: 2026-09-14T22:13:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138306

An Eagle Pharmaceuticals 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke (EHS) has been accepted for priority review. The agency has set a user fee review target date of 7/23.

  
“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.