Eagle Pharmaceuticals announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter for the New Drug Application (NDA) of Kangio (bivalirudin injection) 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).
The letter communicated the FDA’s decision to deny the application in its present form after completing the initial review of the NDA. The FDA also requested additional information and further characterization of bivalirudin-related substances in the drug product. Eagle will work closely with the agency to determine the appropriate steps to take to address the FDA’s requests.
Kangio is a ready-to-use (RTU), stable liquid intravenous formulation of 5mg/mL bivalirudin in a 50mL vial.