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Buprenorphine AND Naloxone · Regulatory label update
U.S. Food and Drug Administration · August 14, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval (REMS submission) for buprenorphine–naloxone combination film products in two dosage strengths, approved on 14 August 2026 by Mylan Technologies. The record is administrative and does not contain clinical trial results, efficacy data, or safety comparisons; it documents regulatory authorization of a risk management strategy for an existing opioid agonist–antagonist combination.
Regulatory label update. Intervention: Buprenorphine hydrochloride 2 mg or 4 mg base + naloxone hydrochloride 0.5 mg or 1 mg base, buccal–sublingual film formulation, subject to REMS requirements.
Supplemental approval granted for buprenorphine 4 mg / naloxone 1 mg buccal–sublingual film formulation Supplemental approval granted for buprenorphine 2 mg / naloxone 0.5 mg buccal–sublingual film formulation Submission class: REMS (Risk Evaluation and Mitigation Strategy)
This record contains no clinical trial data, efficacy endpoints, safety outcomes, or comparative analysis
This approval does not provide clinical evidence of efficacy, safety, or comparative benefit. Clinicians should refer to the approved label and REMS requirements; no new efficacy or safety data are presented in this record.
FDA supplemental approval of a REMS (Risk Evaluation and Mitigation Strategy) for an existing buprenorphine–naloxone combination product; this is a regulatory action, not a clinical trial, and does not report efficacy or safety data.
As stated by the source record.
Quoted from the source exactly as published.
This approval does not provide clinical evidence of efficacy, safety, or comparative benefit. Clinicians should refer to the approved label and REMS requirements; no new efficacy or safety data are presented in this record.
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.
Drugs@FDA record for application ANDA211785. This is a regulatory action record, not a clinical study. Brand name: BUPRENORPHINE AND NALOXONE. Active ingredient: BUPRENORPHINE AND NALOXONE. Sponsor: MYLAN TECHNOLOGIES. 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 4MG BASE + NALOXONE HYDROCHLORIDE EQ 1MG BASE; BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, FILM, BUCCAL, SUBLINGUAL, BUPRENORPHINE HYDROCHLORIDE EQ 2MG BASE + NALOXONE HYDROCHLORIDE EQ 0.5MG BASE.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.