Bristol Pravachol receives reduction in MI, slowing of atherosclerosis indications.
Executive Summary
BRISTOL-MYERS SQUIBB's PRAVACHOL INDICATION FOR REDUCING MI RISK and slowing the progression of coronary atherosclerosis was approved by FDA March 22. NDA 19-898/S-013 provides two additional indications for the HMG-CoA reductase inhibitor pravastatin: "(1) slowing the progression of coronary atherosclerosis and (2) reducing the risk of acute coronary events in patients with hypercholesterolemia and established coronary disease."