Pentazocine Hydrochloride AND Naloxone Hydrochloride

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Pentazocine AND Naloxone (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a fixed-dose pentazocine-naloxone combination tablet under a Risk Evaluation and Mitigation Strategy (REMS), establishing regulatory authorization for this opioid formulation with abuse-deterrent properties.

JUN 18, 2026 · REGULATORY LABEL UPDATE

FDA supplemental approval: Pentazocine Hydrochloride AND Naloxone Hydrochloride (REMS)

U.S. Food and Drug Administration

FDA supplemental approval of a pentazocine–naloxone combination tablet with REMS requirements; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.