Angiomax Gains Second Label Expansion For 2005
This article was originally published in The Pink Sheet Daily
Executive Summary
Supplement cleared Nov. 30 allows use of the anticoagulant bivalirudin in percutaneous coronary intervention patients at risk for heparin-induced thrombocytopenia or thrombosis syndrome.
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The Medicines Company Seeks To Sharpen Angiomax Label With ACUITY Data
An acute coronary syndromes claim based on ACUITY would open up nearly 2 million additional potential patients per year for the anticoagulant, COO Kelley tells “The Pink Sheet” DAILY.
The Medicines Company Seeks To Sharpen Angiomax Label With ACUITY Data
An acute coronary syndromes claim based on ACUITY would open up nearly 2 million additional potential patients per year for the anticoagulant, COO Kelley tells “The Pink Sheet” DAILY.
Angiomax Approved For Use In Percutaneous Coronary Intervention
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.