Angiomax Approved For Use In Percutaneous Coronary Intervention
This article was originally published in The Pink Sheet Daily
Executive Summary
The indication includes “provisional” use with concomitant glycoprotein IIb/IIIa inhibitors. FDA had previously found the supplemental NDA, based on the REPLACE-2 study, “not approvable.” The Medicines Company appears not to have needed an additional study.