18 March 2016 - Eagle Pharmaceuticals, today announced that it has received a Complete Response Letter from the U.S. FDA for Kangio (bivalirudin), a new drug application for a ready-to-use, 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 with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty.

The FDA issues Complete Response Letters to communicate that their initial review of an application is complete; however, they cannot approve the application in its present form and request additional information. In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product. Eagle will work directly with the FDA to determine an appropriate path forward to address the comments.

For more details, go to: http://investor.eagleus.com/press-release/eagle-pharmaceuticals-receives-complete-response-letter-fda-kangio-rtu-bivalirudin-app