MAR 24, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Xarelto (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling change of an established anticoagulant; documents regulatory action but does not report clinical trial outcomes or comparative efficacy data.
Reported
Submission classLabeling
Approval status date2026-03-24
Formulation concentration1 MG/ML