In answer to New Jersey-based Eagle Pharmaceuticals Inc.’s New Drug Application (NDA) for Ryanodex (dantrolene sodium) to treat exertional heat stroke (EHS), the U.S. Food and Drug Administration recently issued a Complete Response Letter.
Complete Response Letters originated in 2008, replacing a discontinued communication category. They are issued to let a company know that its NDA has been fully reviewed but will not be approved in its current form. Contents are not generally made public; rather, only the status itself is announced.
“We are reviewing our options and will evaluate the FDA’s response to chart a path forward for Ryanodex for this important indication and life-threatening condition,” Eagle CEO Scott Tarriff said.
While FDA has asked Eagle to perform another clinical trial for Ryanodex as it pertains to treating EHS in tandem with external cooling treatments, use of the medication remains authorized for malignant hyperthermia with proper supportive measures, as well as for the preventing the disorder in high risk individuals.
From its headquarters in Woodcliff Lake, New Jersey, Eagle concentrates on developing injectable medications that successfully surpass limitations of similar products already on the market. The company uses the FDA's standard 505(b)(2) regulatory pathway.