This 505(b)(2) NDA requests FDA approval of Eagle’s RTU bivalirudin product for the treatment of patients: undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, undergoing PCI with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome, or with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).
"We look forward to the FDA’s decision on this NDA in March 2016 and, if approved, intend to launch our RTU bivalirudin product the following day," said Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.
"We expect our RTU liquid formulation will be well received due to its multiple differentiating features. We look forward to continuing to work closely with the FDA through the review process."
Eagle’s RTU bivalirudin product, which contains the same active ingredient as Angiomax, is administered as an IV solution at the same dose and rate.
Eagle’s liquid formulation will allow for immediate administration, with no reconstitution nor initial dilution required, reducing work flow and the risk of dosing errors.
Eagle’s intellectual property pertaining to RTU bivalirudin includes two issued patents and an additional patent pending at the U.S. Patent and Trademark Office.