MAY 7, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Capecitabine (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval action for capecitabine labeling; documents a regulatory decision but contains no clinical trial data or efficacy evidence.
Reported
Approval date2026-05-07
Product strengths approved150 mg and 500 mg tablets, oral
Submission typeSupplemental labeling