MAY 15, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Argatroban (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling changes to argatroban; regulatory action without new clinical trial data or efficacy claims.
Reported
Approval status date2026-05-15
Formulation 1ARGATROBAN 50MG/50ML (1MG/ML)
Formulation 2ARGATROBAN 250MG/2.5ML (100MG/ML)