The USFDA has scheduled a Gastrointestinal Drugs Advisory Committee (GIDAC) meeting on Friday, May 18, 2023. The committee will meet to discuss new drug application (NDA- 212833) for Obeticholic acid (OCA) 25 mg oral tablets, submitted by Intercept Pharmaceuticals, Inc., for the treatment of pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis.
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Earlier Event: May 18
Vaccines and Related Biological Products Advisory Committee
Later Event: June 8
Antimicrobial Drugs Advisory Committee