Eagle Pharmaceuticals has received a complete response letter from the FDA for its ready-to-use, stable liquid intravenous formulation of bivalirudin (5 mg/mL in a 50-mL vial). The treatment is intended for use as an anticoagulant in patients 1) undergoing percutaneous coronary intervention (PCI) with the 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 product is a stable liquid formulation of the same active ingredient in Angiomax (Medicines Company).
The FDA issues complete response letters to communicate that the agency’s initial review of an application is complete, but the FDA cannot approve the application in its present form and requires additional information. In its letter to Eagle, the FDA requested further characterization of bivalirudin-related substances in the drug product.
Eagle submitted its new drug application for ready-to-use bivalirudin in May 2015.
Sources: Eagle Pharmaceuticals; March 18, 2016; and Reuters; May 20, 2015.