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# Updated Xeloda Labeling Approved
- URL: https://www.fdaweb.com/updated-xeloda-labeling-approved/
- Published: 2022-12-15T12:00:00.000Z
- Updated: 2026-09-14T18:09:54.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153406

FDA has approved updated labeling for Genentech’s Xeloda (capecitabine) tablets. An agency [announcement](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-updated-drug-labeling-including-new-indications-and-dosing-regimens-capecitabine?ref=fdaweb.com) says the revised labeling was approved under Project Renewal, an Oncology Center of Excellence initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. Xeloda is the first drug to receive a Project Renewal update, FDA says.

The announcement lists the drug’s new and revised indications and additional labeling revisions.