Fentanyl

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Fentanyl (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for fentanyl transdermal film products; this is a regulatory action, not a clinical trial, and does not report efficacy or safety trial outcomes.