News
FDA accepts NDA for obeticholic acid seeking accelerated approval for treatment of patients with pre-cirrhotic liver fibrosis due to NASH
Intercept Pharmaceuticals, Inc. announced that the FDA has accepted Intercept’s New Drug Application (NDA) for obeticholic acid (OCA) seeking accelerated approval for the treatment of patients with pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH)
The FDA indicated that it considers this a complete, Class 2 resubmission and has assigned a Prescription Drug User Fee Act (PDUFA) target action date of June 22, 2023, for the NDA. The timeline for the review of the NDA by FDA remains subject to change.
Condition: Liver Fibrosis/NASH
Type: drug
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.