> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Seeks Another Trial on Eagle Pharma’s Ryanodex
- URL: https://www.fdaweb.com/fda-seeks-another-trial-on-eagle-pharmas-ryanodex/
- Published: 2017-07-26T12:00:00.000Z
- Updated: 2026-09-14T22:36:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139231

FDA has sent Eagle Pharmaceuticals a complete response letter on its 505(b)(2) NDA for Ryanodex (dantrolene sodium) for treating exertional heat stroke in conjunction with external cooling methods. The letter asked that the company conduct an additional clinical trial. Currently, Ryanodex is approved for treating malignant hyperthermia in conjunction with appropriate supportive measures, and for preventing malignant hyperthermia in patients at high risk. Eagles says it is reviewing its options.