Additional Relevant Details Eagle Pharmaceuticals  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 angina undergoing percutaneous transluminal coronary angioplasty (“PTCA”).