FDA Accepts Ready-to-Use Bivalirudin NDA for Filing
Eagle Pharmaceuticals announced that the New Drug Application (NDA) for ready-to-use (RTU) bivalirudin has been accepted for filing by the Food and Drug Administration (FDA) for the treatment of patients undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIa inhibitor; undergoing PCI with, or at risk of heparin-induced thrombocytopenia and thrombosis syndrome; or with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
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RTU bivalirudin contains the same active ingredient as Angiomax and is administered as an IV solution at the same dose and rate. The company's liquid formulation will allow for immediate administration with no reconstitution nor initial dilution required.
For more information call (201) 326-5300 or visit EagleUS.com.