Eagle Pharma Issues Statement Regarding RYANODEX Application PDUFA Date For Exertional Heat Stroke
Published: Jul 25, 2017
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq: EGRX) today issued a statement that it has not yet received correspondence from the US Food and Drug Administration (FDA) regarding its 505(b)(2) New Drug Application for RYANODEX® (dantrolene sodium) for the treatment of exertional heat stroke. Under the Prescription Drug User Fee Act (PDUFA), the FDA’s goal is to review 90 percent of NDAs on time. The NDA for RYANODEX was accepted for Priority Review, with review timelines within six months of the NDA submission. The PDUFA date was Sunday, July 23, 2017.
Eagle will issue a press release once the FDA has made its determination and communicates with the Company.
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.