Butrans

Manages severe and persistent pain. NDA 21306, held by Knoa Pharma. Buprenorphine.

As of Nov 14, 2026, NDA 21306 (Butrans), held by Knoa Pharma, was first approved by FDA on Jun 30, 2010, with 26 approved supplements and 0 published complete response letters.

First approved: Jun 30, 2010
Review: Standard
Supplements approved: 26
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Buprenorphine transdermal system is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy, reserve opioid analgesics, including buprenorphine transdermal system, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 27 submissions below


Oct 13, 2017	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Jun 30, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Label

Products

5 strengths and forms


Butrans5MCG/HR · film, extended release;transdermal	Buprenorphine	RxReference drug
Butrans10MCG/HR · film, extended release;transdermal	Buprenorphine	RxReference drug
Butrans20MCG/HR · film, extended release;transdermal	Buprenorphine	RxReference drug
Butrans15MCG/HR · film, extended release;transdermal	Buprenorphine	RxReference drug
Butrans7.5MCG/HR · film, extended release;transdermal	Buprenorphine	RxReference drug

All 27 submissions, including labeling and manufacturing supplements


Jun 18, 2026	Supplement 45REMS	Approved	Letter
Dec 22, 2025	Supplement 44Labeling · Standard review	Approved	Label Letter
Oct 31, 2024	Supplement 42REMS	Approved	Letter
Dec 15, 2023	Supplement 41Labeling · Standard review	Approved	Letter Label Medication Guide
Jun 17, 2022	Supplement 39Labeling · Standard review	Approved	Letter Label
Mar 4, 2021	Supplement 37Labeling · Standard review	Approved	Label Letter
Oct 7, 2019	Supplement 35Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 34Labeling · Standard review	Approved	Label Letter
Sep 18, 2018	Supplement 32REMS	Approved	Label Letter
Oct 13, 2017	Supplement 27Efficacy (new indication or use) · Standard review	Approved	Label Letter Pediatric Medical Review Pediatric Clinical Pharmacology Review
Aug 14, 2017	Supplement 31REMS	Approved	Letter
May 26, 2017	Supplement 30REMS	Approved	Label
Dec 16, 2016	Supplement 24Labeling · Standard review	Approved	Label Letter
Sep 30, 2016	Supplement 26REMS	Approved	Letter
Apr 20, 2016	Supplement 23REMS	Approved	Letter
Jun 26, 2015	Supplement 22REMS	Approved	Letter
Aug 19, 2014	Supplement 20REMS	Approved	Letter
Jun 30, 2014	Supplement 19Manufacturing · Standard review	Approved	Label Letter
Jun 30, 2014	Supplement 15Labeling · Standard review	Approved	Label Letter
Apr 16, 2014	Supplement 18Labeling	Approved	Letter Label
Jul 25, 2013	Supplement 16Manufacturing · Standard review	Approved	Label Letter
Apr 15, 2013	Supplement 12REMS	Approved	Letter
Mar 8, 2013	Supplement 13Manufacturing · Standard review	Approved	None posted
Jul 9, 2012	Supplement 8Labeling · Standard review	Approved	Label Letter
Jul 1, 2011	Supplement 3Labeling · Standard review	Approved	Letter Label
Jul 1, 2011	Supplement 1Labeling · Standard review	Approved	Letter Label
Jun 30, 2010	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Other Label

Identifiers

Application: NDA 21306
Drugs@FDA: Overview at FDA
Company: KNOA Pharma

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