Ryanodex dantrolene regulatory update

FDA accepted and granted Priority Review to an NDA from Eagle Pharmaceuticals for Ryanodex dantrolene to treat malignant hyperthermia. The PDUFA date is July 22. Ryanodex is a lyophilized formulation of the muscle relaxant dantrolene, which reverses the signs of malignant hyperthermia. Eagle said Ryanodex can be reconstituted in less than a minute compared to the 15-20 minutes required for marketed formulations of dantrolene. The company is developing Ryanodex under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from scientific literature or from previously approved products. ...