Posted by Michael Wonder on 20 Jan 2020
FDA delays decision on Intercept's NASH drug by three months
20 January 2020 - Action date pushed back to 26 June.
The US Food and Drug Administration has pushed back the date on which it is due to decide whether to approve Intercept Pharmaceuticals’ non-alcoholic steatohepatitis drug.
Originally, the FDA gave Intercept’s obeticholic acid a Prescription Drug User Fee Act target action date of 26 March. However, it became clear late last year that the FDA would miss that PDUFA date.
