Omacor Potential To Increase LDL Cholesterol Limits Use To Severe Patients
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Omacor indication limited to severe hypertriglyceridemia because of increased LDL-cholesterol associated with the drug, FDA review documents indicate. Ross was unable to support cardioprotective benefit or reduction of risk of pancreatitis; omega-3 fatty acids, also marketed in U.S. as a dietary supplement, is approved for cardiovascular outcomes in other countries