Despite Positive Efficacy, Advisory Cmte. Says Solvay’s Pulzium Too Risky
Executive Summary
Despite positive efficacy for Solvay's atrial fibrillation drug Pulzium, FDA's Cardiovascular and Renal Drugs Advisory Committee voted unanimously against its approval - in part due to safety risks in the form of adverse events as serious as torsade de pointes and in part because the pivotal trial was a non-U.S. study
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