Teva and Eagle Pharmaceuticals Announce NDA for Bendamustine Rapid Infusion Product Accepted for Filing . April 14, 2015 08:00 AM Eastern Daylight Time.

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 ...

Eagle (EGRX) announced that it has completed the submission of its 505(b)(2) NDA in the U.S. for Ryanodex for the treatment of exertional heat stroke.