Treats malignant hyperthermia in conjunction with appropriate supportive measures. NDA 205579, held by Eagle Pharms. Dantrolene Sodium.
As of Nov 13, 2026, NDA 205579 (Ryanodex), held by Eagle Pharms, was first approved by FDA on Jul 22, 2014, with 3 approved supplements and 0 published complete response letters.
RYANODEX is indicated for the: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures Prevention of malignant hyperthermia in patients at high risk. RYANODEX is a skeletal muscle relaxant drug indicated for: Treatment of malignant hyperthermia in conjunction with appropriate supportive measures. Prevention of malignant hyperthermia in patients at high risk.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 22, 2014 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ryanodex250MG/VIAL · for suspension;intravenous | Dantrolene Sodium | RxReference drug |
| Apr 2, 2024 | Supplement 11Labeling · Standard review | Approved | |
| Aug 25, 2020 | Supplement 7Labeling · Standard review | Approved | |
| Oct 1, 2015 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Jul 22, 2014 | Original applicationNew dosage form · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
