MAY 1, 2026 · REGULATORY APPROVAL
FDA approval: Evdi (Type 5 - New Formulation or New Manufacturer)
U.S. Food and Drug Administration
FDA approval of a new formulation/manufacturer of trabectedin; this is a regulatory action record without clinical trial data or efficacy comparisons.
Reported
Approved concentration0.05 mg/mL
Approved dose unit1 mg/20 mL
Approval date2026-05-01