FDA Floats Minimum Efficacy Requirement To Nebivolol/Valsartan Panel
This article was originally published in The Pink Sheet Daily
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.
You may also be interested in...
Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.
Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials.
US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.