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FDA Accepts Intercept’s (ICPT) NDA for Obeticholic Acid in Liver Fibrosis Due to NASH and Grants Priority Review

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Additional Information

Additional Relevant Details The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 26, 2020 for the NDA. In the NDA filing acceptance notification letter, the FDA also indicated that it currently plans to hold an advisory committee meeting to discuss the application. A date for the advisory committee meeting has not been finalized and the timeline for the review of the NDA by the FDA remains subject to change.
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Occurred on:
Nov 25, 2019
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Related Keywords Obeticholic Acid, Nash Fibrosis, Liver Fibrosis