Posted by Michael Wonder on 16 Jul 2018
U.S. FDA extends review timeline for Invokana (canagliflozin) supplemental new drug application
13 July 2018 - The application seeks a new indication for Invokana to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus who have established cardiovascular disease or are at risk for cardiovascular disease.
The application also applies to Invokana fixed-dose combinations, Invokamet and Invokamet XR, and is based on data from the Phase 3 CANVAS Program.
