Buprenorphine

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine Transdermal System (REMS)

U.S. Food and Drug Administration

FDA supplemental approval for buprenorphine transdermal system REMS; regulatory action without reported clinical trial outcomes.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Buprenorphine (REMS)

U.S. Food and Drug Administration

This is an FDA supplemental approval action updating the Risk Evaluation and Mitigation Strategy (REMS) for buprenorphine transdermal film products; it does not report clinical trial efficacy or safety data.