FDA Approves Ryanodex for the Treatment of Malignant - TopicsExpress

FDA Approves Ryanodex for the Treatment of Malignant Hyperthermia WOODCLIFF LAKE, N.J.(BUSINESS WIRE) July 23, 2014 -- Eagle Pharmaceuticals, Inc. (“Eagle” or “the Company”) (Nasdaq:EGRX) today announced that the U. S. Food and Drug Administration (FDA) has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. MH is an inherited and potentially fatal disorder triggered by certain anesthesia agents in genetically susceptible individuals. FDA had designated Ryanodex as an Orphan Drug in August 2013. Eagle has been informed by the FDA that it will learn over the next four to six weeks if it has been granted the seven year Orphan Drug market exclusivity. “We are very pleased with today’s approval of Ryanodex, which enables health care providers to better meet the needs of patients experiencing a life-threatening MH crisis,” said Scott Tarriff, CEO of Eagle Pharmaceuticals. “This significant milestone exemplifies our strategy of developing innovative products and we plan to ship the product in the very near future.” Eagle is the exclusive licensee of four U.S. patents for Ryanodex. Approval of Ryanodex represents two major milestones: in addition to adding to the Company’s portfolio of approved compounds, Ryanodex represents the first product to be solely marketed by the Company.

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