MAY 14, 2026 · REGULATORY LABEL UPDATE
FDA supplemental approval: Lurasidone Hydrochloride (Labeling)
U.S. Food and Drug Administration
FDA supplemental approval of labeling for lurasidone hydrochloride formulations; this is a regulatory action record, not a clinical trial, and contains no efficacy or safety outcome data.
Reported
Approval date2026-05-14
Formulations approved40 mg, 60 mg, 80 mg, 120 mg tablets