Pentazocine Hydrochloride AND Naloxone Hydrochloride · Regulatory label update

FDA supplemental approval: Pentazocine AND Naloxone (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 approved a supplemental application for a fixed-dose combination tablet containing pentazocine hydrochloride 50 mg and naloxone hydrochloride 0.5 mg under a REMS requirement on 18 June 2026. This regulatory action authorizes the formulation but does not itself report clinical efficacy, safety, or comparative trial data.

What was studied

Regulatory label update. Intervention: Pentazocine hydrochloride 50 mg + naloxone hydrochloride 0.5 mg fixed-dose oral tablet.

Key findings

Fixed-dose formulation: pentazocine hydrochloride 50 mg + naloxone hydrochloride 0.5 mg per tablet Approval granted under Risk Evaluation and Mitigation Strategy (REMS) requirement

Safety

This regulatory record does not contain clinical trial efficacy or safety data. No comparative effectiveness, pharmacokinetic data, or trial outcomes are reported.

Who this may help

This approval enables prescribers and patients to access a fixed-dose pentazocine-naloxone combination in oral tablet form subject to REMS requirements. Clinicians should consult the full prescribing information and REMS programme details for indications, dosing, and risk mitigation requirements.

Plain-language summary

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.

Study design

As stated by the source record.

InterventionPentazocine hydrochloride 50 mg + naloxone hydrochloride 0.5 mg fixed-dose oral tablet

Reported figures

Quoted from the source exactly as published.

Pentazocine dose50 mg

Naloxone dose0.5 mg

Approval date2026-06-18

Clinical bottom line

Caveats

This regulatory record does not contain clinical trial efficacy or safety data.
No comparative effectiveness, pharmacokinetic data, or trial outcomes are reported.
REMS requirements and their clinical or patient-reported impact are not described in this record.
Rationale for the naloxone dose (0.5 mg base) and its abuse-deterrent mechanism are not detailed here.

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 clinical trial design reported.

Directness

insufficient

This is an approval action, not a clinical outcome study.

Consistency

insufficient

No comparative or replicate data presented in this record.

Risk of bias

insufficient

Regulatory approval records do not report trial-level bias assessment.

Sample adequacy

insufficient

No clinical trial sample size or population data reported here.

Source abstract

Drugs@FDA record for application ANDA074736. This is a regulatory action record, not a clinical study. Brand name: PENTAZOCINE AND NALOXONE. Active ingredient: PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Sponsor: WATSON LABS. 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.

Watson LabsPentazocine Hydrochloride AND Naloxone Hydrochloride