Pentazocine Hydrochloride AND Naloxone Hydrochloride · Regulatory label update

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

U.S. Food and Drug Administration · June 18, 2026

Regulatory Update Why this matters to you Expert discussion

An action by a regulator. Authoritative on labelling and availability.

AI Summary

The FDA granted a supplemental approval for a pentazocine hydrochloride–naloxone hydrochloride combination tablet under a Risk Evaluation and Mitigation Strategy (REMS) on 18 June 2026. This regulatory action does not report clinical trial results, efficacy data, or safety outcomes; it confirms only that the combination product met FDA requirements for marketing authorisation with mandatory risk mitigation.

What was studied

Regulatory label update. Intervention: Pentazocine hydrochloride 50 mg base + naloxone hydrochloride 0.5 mg base, oral tablet formulation..

Key findings

Supplemental approval granted for pentazocine hydrochloride 50 mg base + naloxone hydrochloride 0.5 mg base oral tablet formulation. Approval requires a REMS (Risk Evaluation and Mitigation Strategy) programme.

Safety

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative benefit information. No information on patient populations, indications, contraindications, or adverse events is provided.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

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.

Study design

As stated by the source record.

InterventionPentazocine hydrochloride 50 mg base + naloxone hydrochloride 0.5 mg base, oral tablet formulation.

Reported figures

Quoted from the source exactly as published.

Pentazocine strength50 mg base

Naloxone strength0.5 mg base

Approval date2026-06-18

Caveats

This record does not contain clinical trial results, efficacy data, safety outcomes, or comparative benefit information.
REMS requirements are mentioned but their specific terms are not detailed in this record.
No information on patient populations, indications, contraindications, or adverse events is provided.
Supplemental approval status does not clarify what change or addition this supplemental application addressed.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

insufficient

Regulatory record; no study design applicable.

Directness

insufficient

Approval action; clinical endpoints not reported.

Consistency

insufficient

Single regulatory action; no comparative data provided.

Risk of bias

insufficient

Regulatory record does not assess trial bias.

Sample adequacy

insufficient

No trial population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA075735. This is a regulatory action record, not a clinical study. Brand name: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Active ingredient: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Sponsor: LUPIN. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, TABLET, ORAL, NALOXONE HYDROCHLORIDE EQ 0.5MG BASE + PENTAZOCINE HYDROCHLORIDE EQ 50MG BASE.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

LupinPentazocine Hydrochloride AND Naloxone Hydrochloride