Eagle Pharmaceuticals, Inc. EGRX 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).
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
See full press release
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