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Treats pulmonary arterial hypertension (PAH) (WHO Group 1). NDA 209279, held by Actelion. Bosentan.
As of Nov 13, 2026, NDA 209279 (Tracleer), held by Actelion, was first approved by FDA on Sep 5, 2017, with 13 approved supplements and 0 published complete response letters.
First approved: Sep 5, 2017
Review: Standard
Supplements approved: 13
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.
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
