Eagle Pharmaceuticals, Inc. today announced that the 505(b)(2) New Drug Application (NDA) for its novel ready-to-use bivalirudin product (“RTU bivalirudin”) has been accepted for filing by the U.S. Food and Drug Administration (FDA).

“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.”

This 505(b)(2) NDA requests FDA approval of Eagle’s RTU bivalirudin product for the treatment of 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 and thrombosis syndrome, or (3) 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.”

For more details, go to: http://www.businesswire.com/news/home/20150723005239/en/Eagle-Pharmaceuticals’-RTU-Bivalirudin-NDA-Accepted-Filing#.VbLAoXjC1MI