Posted by Michael Wonder on 19 Jan 2023
FDA accepts Intercept’s new drug application for OCA for the treatment of pre-cirrhotic liver fibrosis due to NASH
19 January 2023 - PDUFA target action date set for 22 June 2023.
Intercept Pharmaceuticals today announced that the US FDA has accepted Intercept’s new drug application for obeticholic acid seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis.
