Buprenorphine AND Naloxone · Regulatory label update

FDA supplemental approval: Buprenorphine AND Naloxone Sublingual Film (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

This is a supplemental FDA approval (REMS submission) for a buprenorphine/naloxone sublingual film product by Alvogen, approved on 14 August 2026. The record does not include clinical trial results, efficacy data, or safety evidence; it documents only the regulatory action and product specifications.

What was studied

Regulatory label update. Intervention: Buprenorphine hydrochloride 2, 4, 8, or 12 mg base equivalent + naloxone hydrochloride 0.5, 1, 2, or 3 mg base equivalent, sublingual film formulation.

Key findings

Four formulation strengths approved: 2/0.5 mg, 4/1 mg, 8/2 mg, and 12/3 mg (buprenorphine/naloxone base equivalents)

Safety

This is a regulatory action record, not a clinical trial. No efficacy, safety, or comparative effectiveness data are reported.

Who this may help

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

Plain-language summary

FDA supplemental approval of a buprenorphine/naloxone sublingual film under REMS; this is a regulatory action, not a clinical evidence report.

Study design

As stated by the source record.

InterventionBuprenorphine hydrochloride 2, 4, 8, or 12 mg base equivalent + naloxone hydrochloride 0.5, 1, 2, or 3 mg base equivalent, sublingual film formulation

Reported figures

Quoted from the source exactly as published.

Approval date2026-08-14

Caveats

This is a regulatory action record, not a clinical trial. No efficacy, safety, or comparative effectiveness data are reported.
REMS designation indicates restricted distribution requirements; specific terms are not detailed in this record.
Record does not state whether approval was standard or accelerated, nor does it include review comments, advisory committee input, or post-market commitments.
No clinical population, dosing rationale, or outcome data are provided.

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 study design reported.

Directness

insufficient

Record does not contain clinical trial outcomes or efficacy data.

Consistency

insufficient

No comparative or supporting trial data provided in this record.

Risk of bias

insufficient

Not applicable; regulatory action record, not a clinical trial.

Sample adequacy

insufficient

No sample size or clinical population data reported.

Source abstract

Drugs@FDA record for application ANDA205954. This is a regulatory action record, not a clinical study. Brand name: BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM. Active ingredient: BUPRENORPHINE AND NALOXONE. Sponsor: ALVOGEN. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-08-14. Products: BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, FILM, BUCCAL, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 12MG BASE + NALOXONE HYDROCHLORIDE EQ 3MG BASE; BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, FILM, BUCCAL, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 4MG BASE + NALOXONE HYDROCHLORIDE EQ 1MG BASE; BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, FILM, BUCCAL, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 8MG BASE + NALOXONE HYDROCHLORIDE EQ 2MG BASE; BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, FILM, BUCCAL, 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 NaloxoneAlvogen