Buprenorphine Hydrochloride · Regulatory label update

FDA supplemental approval: Buprenorphine Hydrochloride AND Naloxone Hydrochloride (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 REMS (Risk Evaluation and Mitigation Strategy) for buprenorphine/naloxone sublingual tablets in two strengths (2/0.5 mg and 8/2 mg base). This is a regulatory action governing safe use and distribution, not a clinical trial or efficacy determination.

What was studied

Regulatory label update. Patients eligible for buprenorphine/naloxone treatment under the approved REMS program; this record does not specify clinical eligibility criteria.. Intervention: Buprenorphine hydrochloride/naloxone hydrochloride sublingual tablets in two strengths (2/0.5 mg and 8/2 mg base); approval of supplemental REMS.

Key findings

Supplemental REMS approval for buprenorphine hydrochloride 2 mg base + naloxone hydrochloride 0.5 mg base sublingual tablets Supplemental REMS approval for buprenorphine hydrochloride 8 mg base + naloxone hydrochloride 2 mg base sublingual tablets Approval date: 2026-08-14; Sponsor: TEVA PHARMS USA

Safety

This is a regulatory approval record, not a clinical trial; no efficacy, safety trial results, or comparative outcomes are reported. No information is provided on the rationale for the REMS supplement, prior safety signals, or changes to existing REMS requirements.

Who this may help

This approval does not report efficacy, safety, or comparative clinical outcomes. Clinicians should consult the full REMS requirements and prescribing information to understand distribution restrictions and monitoring obligations. The action confirms regulatory authorisation but carries no data on clinical superiority or new safety findings.

Plain-language summary

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

Study design

As stated by the source record.

InterventionBuprenorphine hydrochloride/naloxone hydrochloride sublingual tablets in two strengths (2/0.5 mg and 8/2 mg base); approval of supplemental REMS

Reported figures

Quoted from the source exactly as published.

Buprenorphine strength (lower dose)2 mg base

Naloxone strength (lower dose)0.5 mg base

Buprenorphine strength (higher dose)8 mg base

Naloxone strength (higher dose)2 mg base

Approval status date2026-08-14

Clinical bottom line

Caveats

This is a regulatory approval record, not a clinical trial; no efficacy, safety trial results, or comparative outcomes are reported.
The REMS submission class and content are not detailed; specific risk minimisation measures are not described in this record.
No information is provided on the rationale for the REMS supplement, prior safety signals, or changes to existing REMS requirements.
This record does not report patient enrolment, outcomes, or follow-up data.

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 with a design.

Directness

insufficient

Source does not report clinical outcomes or efficacy data.

Consistency

insufficient

Source does not compare outcomes or report consistency with other studies.

Risk of bias

insufficient

Risk of bias assessment is not applicable to regulatory approval records.

Sample adequacy

insufficient

This is a regulatory record; no patient sample is described or analysed.

Source abstract

Drugs@FDA record for application ANDA091149. This is a regulatory action record, not a clinical study. Brand name: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Active ingredient: BUPRENORPHINE HYDROCHLORIDE. Sponsor: TEVA PHARMS USA. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-08-14. Products: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, TABLET, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE + NALOXONE HYDROCHLORIDE EQ 0.5MG BASE; BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, TABLET, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE + NALOXONE HYDROCHLORIDE EQ 2MG BASE.

Follow from this

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

Buprenorphine HydrochlorideTeva Pharms U