Tracleer

Treats pulmonary arterial hypertension (PAH) (WHO Group 1). NDA 21290, held by Actelion. Bosentan.

As of Nov 14, 2026, NDA 21290 (Tracleer), held by Actelion, was first approved by FDA on Nov 20, 2001, with 34 approved supplements and 0 published complete response letters.

First approved: Nov 20, 2001
Review: Standard
Supplements approved: 34
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRACLEER is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1): in adults to improve exercise ability and to decrease clinical worsening. Studies establishing effectiveness included predominantly patients with WHO Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (60%), PAH associated with connective tissue diseases (21%), and PAH associated with congenital heart disease with left-to-right shunts (18%). in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 35 submissions below


Oct 4, 2012	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 7, 2009	Supplement 12Efficacy (new indication or use)	Approved	Letter Summary Review Label
Feb 15, 2007	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Nov 29, 2005	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 6, 2003	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 20, 2001	Original applicationNew molecular entity · Standard review	Approved	REMS Label Review Letter

Products

2 strengths and forms


Tracleer62.5MG · tablet;oral	Bosentan	RxReference drug
Tracleer125MG · tablet;oral	Bosentan	RxReference drug

All 35 submissions, including labeling and manufacturing supplements


Oct 27, 2026	Supplement 51REMS	Approved	None posted
Mar 3, 2026	Supplement 50REMS	Approved	Letter
Nov 5, 2025	Supplement 48Labeling	Approved	Label Medication Guide Letter
Jul 30, 2025	Supplement 47Labeling · Standard review	Approved	Letter Label
Feb 21, 2025	Supplement 46REMS	Approved	None posted
Sep 17, 2024	Supplement 45REMS	Approved	Letter
Feb 8, 2024	Supplement 44Labeling · Standard review	Approved	Label Letter
Jun 6, 2023	Supplement 42Labeling · Standard review	Approved	Label Letter
Apr 29, 2022	Supplement 43REMS	Approved	Review Letter
May 16, 2019	Supplement 39Labeling · Standard review	Approved	Label Letter
Apr 26, 2019	Supplement 32REMS	Approved	Label Letter
Oct 25, 2018	Supplement 37Labeling · Standard review	Approved	Letter Label
Oct 20, 2017	Supplement 35REMS	Approved	Letter
Sep 5, 2017	Supplement 34REMS	Approved	Letter Label
Dec 16, 2016	Supplement 30REMS	Approved	Letter
Oct 20, 2016	Supplement 33Labeling · Standard review	Approved	Letter Label
Dec 4, 2015	Supplement 29Labeling · Standard review	Approved	Letter Label
Dec 4, 2015	Supplement 27REMS	Approved	Letter Label
Jul 1, 2013	Supplement 25REMS	Approved	Letter Label
Jun 3, 2013	Supplement 24Manufacturing · Standard review	Approved	None posted
Oct 4, 2012	Supplement 22Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 2, 2012	Supplement 20Manufacturing · Standard review	Approved	Label Letter
Feb 8, 2011	Supplement 19Labeling	Approved	Letter Label
Feb 19, 2010	Supplement 18REMS	Approved	Letter
Aug 7, 2009	Supplement 16Labeling · Standard review	Approved	Label Letter
Aug 7, 2009	Supplement 12Efficacy (new indication or use)	Approved	Letter Summary Review Label
Mar 17, 2009	Supplement 15Labeling · Standard review	Approved	Letter Label
Feb 13, 2009	Supplement 14Labeling · Standard review	Approved	Label Letter
Jun 1, 2007	Supplement 11Labeling · Standard review	Approved	Letter
Feb 15, 2007	Supplement 10Efficacy (new indication or use)	Approved	Letter Label
Nov 29, 2005	Supplement 7Labeling · Standard review	Approved	Letter Label
Nov 29, 2005	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 24, 2004	Supplement 4Labeling · Standard review	Approved	Letter
Oct 6, 2003	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Review Label Letter
Nov 20, 2001	Original applicationNew molecular entity · Standard review	Approved	REMS Label Review Letter

Identifiers

Application: NDA 21290
Drugs@FDA: Overview at FDA
Company: Actelion Pharmaceuticals

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