FDA panel to review Boehringer's Pradaxa on 20 September
This article was originally published in Scrip
Executive Summary
The US FDA's cardiovascular and renal drugs advisory committee will review Boehringer Ingelheim's direct thrombin inhibitor Pradaxa (dabigatran) for the prevention of stroke in patients with atrial fibrillation (AF) on 20 September –putting Boehringer in a close race for obtaining the first US approval as a replacement for the widely used anticoagulant warfarin.