FDA Calendar

Company Name Intercept Pharmaceuticals Inc.
Drug Name Obeticholic acid (NDA)
Event Name FDA decision on obeticholic acid for fibrosis due to nonalcoholic steatohepatitis
Event Date 06/26/2020
Outcome Date 05/22/2020
Outcome FDA decision on Obeticholic acid likely to be extended as additional data has been sought
Drug Status Priority review, Original PDUFA date of March 26, 2020, extended to June 26, 2020
Rival Drugs
Market Potential
Other Approvals
Return to FDA Calendar