Eagle Pharmaceuticals receives complete response letter from FDA on Ryanodex for exertional heat stroke application.
Eagle Pharmaceuticals, Inc. announced Wednesday that it has received a complete response letter from the U.S. Food and Drug Administration (FDA) regarding its 505(b)(2) New Drug Application for Ryanodex (dantrolene sodium) for the treatment of exertional heat stroke (EHS), 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.
Ryanodex remains approved for the treatment of malignant hyperthermia in conjunction with appropriate supportive measures, and for the prevention of malignant hyperthermia in patients at high risk.
About Eagle Pharmaceuticals, Inc.
Eagle is a specialty pharmaceutical company focused on developing and commercializing injectable products that address the shortcomings, as identified by physicians, pharmacists and other stakeholders, of existing commercially successful injectable products. Eagle’s strategy is to utilize the FDA’s 505(b)(2) regulatory pathway. Additional information is available on the company’s website at www.eagleus.com.
(Source: Business Wire)
