FDA Floats Minimum Efficacy Requirement To Nebivolol/Valsartan Panel
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA is asking an advisory committee whether the drug poses enough of an efficacy/safety benefit compared to the free combination or other approved antihypertensives. Actavis is contending that the combo is safer than nebivolol solo therapy, another factor FDA is considering as a basis for approval.