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Eagle Pharmaceuticals Receives Complete Response Letter from FDA on KANGIO (RTU bivalirudin) Application
March 18, 2016 6:50 AM EDTWOODCLIFF LAKE, N.J.--(BUSINESS WIRE)-- Eagle Pharmaceuticals, Inc. (NASDAQ: EGRX) (Eagle or the Company) today announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its KANGIO (bivalirudin injection), 505(b)(2) New Drug Application for a ready-to-use (RTU), stable liquid intravenous formulation of 5 mg/mL bivalirudin in a 50-mL vial intended for use as an anticoagulant in patients: (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), and/or (3) with unstable... More
