FDAnews
www.fdanews.com/articles/175190-ryanodex-garners-fda-fast-track-status

Ryanodex Garners FDA Fast Track Status

February 4, 2016

The FDA has awarded Eagle Pharmaceuticals fast track designation for its injectable Ryanodex for the treatment of exertional heat stroke.

Ryanodex previously was approved by the FDA for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, as well as prevention of malignant hyperthermia in high-risk patients.