MAY 29, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Sandimmune (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval for labeling change to Sandimmune (cyclosporine); regulatory action does not report clinical trial outcomes or comparative efficacy.
Reported
Approval status date2026-05-29
Product formulationSOLUTION, ORAL, CYCLOSPORINE 100MG/ML