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.
Reported
Approval date2026-06-18
Application numberANDA207490
Approved dosage strengths5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 20 mcg/hr