Eagle Pharmaceuticals (EGRX) Announces Positive Results from Ryanodex NDA Meeting w/ FDA
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Eagle Pharmaceuticals Reports Positive Outcome From FDA Meeting For RYANODEX For Exertional Heat Stroke NDA Submission
August 9, 2016 6:45 AM EDT-- Hajj Study Results Sufficient for Human Data in Filing --
-- Hybrid Rule (Human and Animal Data) Reaffirmed --
-- Only Completion of Ongoing Animal Studies Required for Submission--
-- Eagle Purchases Royalty Rights to Ryanodex Portfolio --
WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals (Eagle or the Company) (NASDAQ: EGRX) today announced that the U.S. Food and Drug Administration ("FDA") has determined that no additional human safety and efficacy data is required for the... More
