Buprenorphine · Regulatory label update

FDA supplemental approval: Buprenorphine Transdermal System (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

This is an FDA regulatory action approving a supplemental application (REMS) for buprenorphine transdermal system on 18 June 2026. The record documents the regulatory decision and product formulations approved but does not report clinical trial results, efficacy data, or comparative outcomes.

What was studied

Regulatory label update. Intervention: Buprenorphine transdermal film, extended release, four strengths (5, 7.5, 10, 20 mcg/hr).

Key findings

FDA approved supplemental REMS application ANDA207490 for buprenorphine transdermal system on 2026-06-18 Four dosage strengths approved: 5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, and 20 mcg/hr film, extended release, transdermal formulations Sponsor: Strides Pharma Intl

Safety

This record does not contain clinical trial results, efficacy data, or safety outcomes. No information on indication, contraindications, adverse events, or patient population is provided.

Who this may help

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

Plain-language summary

FDA supplemental approval for buprenorphine transdermal system REMS; regulatory action without reported clinical trial outcomes.

Study design

As stated by the source record.

InterventionBuprenorphine transdermal film, extended release, four strengths (5, 7.5, 10, 20 mcg/hr)

Reported figures

Quoted from the source exactly as published.

Approval date2026-06-18

Application numberANDA207490

Approved dosage strengths5 mcg/hr, 7.5 mcg/hr, 10 mcg/hr, 20 mcg/hr

Caveats

This record does not contain clinical trial results, efficacy data, or safety outcomes.
No comparison with other buprenorphine formulations or placebo is reported.
REMS approval is a regulatory/labeling action; clinical evidence underlying the original NDA approval is not included in this document.
No information on indication, contraindications, adverse events, or patient population is 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 action record; no study design reported.

Directness

insufficient

Regulatory record does not report clinical efficacy or comparative data.

Consistency

insufficient

No clinical trial data provided for consistency assessment.

Risk of bias

insufficient

Regulatory record does not contain study methodology or bias information.

Sample adequacy

insufficient

No study population or sample size reported.

Source abstract

Drugs@FDA record for application ANDA207490. This is a regulatory action record, not a clinical study. Brand name: BUPRENORPHINE TRANSDERMAL SYSTEM. Active ingredient: BUPRENORPHINE. Sponsor: STRIDES PHARMA INTL. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: BUPRENORPHINE, FILM, EXTENDED RELEASE, TRANSDERMAL, BUPRENORPHINE 5MCG/HR; BUPRENORPHINE, FILM, EXTENDED RELEASE, TRANSDERMAL, BUPRENORPHINE 20MCG/HR; BUPRENORPHINE, FILM, EXTENDED RELEASE, TRANSDERMAL, BUPRENORPHINE 10MCG/HR; BUPRENORPHINE, FILM, EXTENDED RELEASE, TRANSDERMAL, BUPRENORPHINE 7.5MCG/HR.

Follow from this

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

BuprenorphineStrides Pharma Intl