Pravastatin/aspirin combo
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA's Cardiovascular & Renal Drugs Advisory Committee, at July 18 meeting, recommends approval of co-packaging of 20, 40 and 80 mg doses of Bristol-Myers Squibb's Pravachol (pravastatin) with 81 and 325 mg doses of aspirin for "long-term management to reduce the risk of cardiovascular events in patients with clinically evident coronary disease." The committee had previously voted against approval of a 40 mg pravastatin dose with 81 and 325 mg of aspirin because of the inability to titrate pravastatin, as well as concerns about the potential for excess use of aspirin and the resulting risk of bleeding. BMS also is developing a single tablet version of the combinatio