In Brief: Hoechst-Roussel's Altace (ramipril)
Executive Summary
Hoechst-Roussel's Altace (ramipril): ACE inhibitor is "approvable" May 26 for the new indication of congestive heart failure treatment following MI. The Altace supplemental NDA is based on the 2,006-patient Acute Infarction Ramipril Efficacy (AIRE) trial, which found a 27% risk reduction in all-cause mortality for Altace compared to placebo when the drug was given on days three to 10 following a myocardial infarction...