Brixadi

Treats moderate to severe opioid use disorder. NDA 210136, held by Braeburn. Buprenorphine.

As of Nov 14, 2026, NDA 210136 (Brixadi), held by Braeburn, was first approved by FDA on May 23, 2023, with 4 approved supplements and 3 published complete response letters.

First approved: May 23, 2023
Review: Priority
Supplements approved: 4
Complete response letters: 3

What It's For

From the FDA-approved label (Indications and Usage)

BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. BRIXADI contains buprenorphine, a partial opioid agonist.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
May 23, 2023	Original applicationNew dosage form · Priority review	Approved	Review REMS Letter Label

Complete Response Letters

FDA's published letters for this application; each opens the letter


Dec 15, 2021	BRIXADI (buprenorphine)Facility Inspections, Risk Evaluation And Mitigation Strategy Requirements, Postmarketing Requirements Under 505(0)(3)	Approved
Dec 1, 2020	BRIXADI (buprenorphine)Facility Inspections, Risk Evaluation And Mitigation Strategy Requirements, Postmarketing Requirements Under 505(0)(3)	Approved
Jan 19, 2018	BRIXADI (buprenorphine extended-release)Clinical/Statistical, Nonclinical, Product Quality	Approved

Products

7 strengths and forms


Brixadi8MG/0.16ML (50MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Brixadi16MG/0.32ML (50MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Brixadi24MG/0.48ML (50MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Brixadi32MG/0.64ML (50MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Brixadi64MG/0.18ML (356MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Brixadi96MG/0.27ML (356MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug
Brixadi128MG/0.36ML (356MG/ML) · solution, extended release;subcutaneous	Buprenorphine	RxReference drug

All 5 submissions, including labeling and manufacturing supplements


Dec 22, 2025	Supplement 12Labeling · Standard review	Approved	Label Letter
Aug 29, 2025	Supplement 11REMS	Approved	Letter
Mar 28, 2025	Supplement 8REMS	Approved	Label Letter
Dec 15, 2023	Supplement 4Labeling · Standard review	Approved	Label Letter
May 23, 2023	Original applicationNew dosage form · Priority review	Approved	Review REMS Letter Label

Identifiers

Application: NDA 210136
Drugs@FDA: Overview at FDA
Company: Braeburn Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters