Eagle Pharmaceuticals receives Complete Response Letter from FDA on Kangio application
FDA requests further characterization of bivalirudin-related substances in the drug product.
Eagle Pharmaceuticals has received a Complete Response Letter from the 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).
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.
“We are evaluating the FDA’s response and will work closely with the agency to better understand and address their comments regarding Kangio,” said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals. “We remain committed to Kangio as an important new formulation of bivalirudin for intravenous use, offering multiple benefits for patients and care givers,” concluded Tarriff.
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