GSK Coreg "approvable"
Executive Summary
GlaxoSmithKline receives "approvable" letter for Coreg (carvedilol) for severe heart failure Aug. 31. Final approval awaits further labeling discussions with FDA, GSK says. The sNDA was filed in March and received priority review. GSK CEO J.P. Garnier referred to Coreg as his "pet project" during Bear Stearns' healthcare conference Sept. 24. Carvedilol is currently approved for hypertension and mild to moderate heart failure