Posted by Michael Wonder on 27 Jul 2017
Eagle Pharmaceuticals receives complete response letter from FDA on Ryanodex for exertional heat stroke application
26 July 2017 - Eagle Pharmaceuticals announced today that it has received a complete response letter from the U.S. FDA regarding its 505(b)(2) new drug application for Ryanodex (dantrolene sodium) for the treatment of exertional heat stroke, in conjunction with external cooling methods.
In its letter to Eagle, the FDA has requested that the Company conduct an additional clinical trial for Ryanodex for exertional heat stroke.
“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,” said Scott Tarriff, Chief Executive Officer of Eagle.
