Buprenorphine AND Naloxone · Regulatory label update

FDA supplemental approval: Buprenorphine AND Naloxone (REMS)

U.S. Food and Drug Administration · August 14, 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 Risk Evaluation and Mitigation Strategy (REMS) for buprenorphine and naloxone combination tablets (8/2 mg and 2/0.5 mg sublingual formulations) manufactured by Alkem Labs Ltd, effective 14 August 2026. This is a regulatory action record that does not contain clinical trial results, efficacy data, or safety findings.

What was studied

Regulatory label update.

Key findings

FDA approved REMS supplement for buprenorphine/naloxone combination on 14 August 2026 Two sublingual tablet strengths approved: 8 mg buprenorphine/2 mg naloxone and 2 mg buprenorphine/0.5 mg naloxone Sponsor: Alkem Labs Ltd

Safety

This record does not contain clinical trial results, efficacy data, or safety findings

Who this may help

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

Plain-language summary

FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing buprenorphine/naloxone combination; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-14

Buprenorphine dose (formulation 1)8 mg base

Naloxone dose (formulation 1)2 mg base

Buprenorphine dose (formulation 2)2 mg base

Naloxone dose (formulation 2)0.5 mg base

Caveats

This record does not contain clinical trial results, efficacy data, or safety findings
No information on indication, patient population, or clinical outcomes is provided
REMS approval relates to risk management strategy, not assessment of clinical benefit
No comparative data or baseline efficacy information is reported

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

This is a regulatory action record, not a clinical study.

Directness

insufficient

Record does not report clinical outcomes or trial results.

Consistency

insufficient

No comparative data or outcome data presented in record.

Risk of bias

insufficient

Record does not describe study methods or conduct.

Sample adequacy

insufficient

No sample size or patient population data reported.

Source abstract

Drugs@FDA record for application ANDA214930. This is a regulatory action record, not a clinical study. Brand name: BUPRENORPHINE AND NALOXONE. Active ingredient: BUPRENORPHINE AND NALOXONE. Sponsor: ALKEM LABS LTD. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-08-14. Products: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, TABLET, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE + NALOXONE HYDROCHLORIDE EQ 2MG BASE; BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, TABLET, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE + NALOXONE HYDROCHLORIDE EQ 0.5MG BASE.

Follow from this

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

Buprenorphine AND NaloxoneAlkem Labs