Treats pulmonary arterial hypertension (PAH) (WHO Group 1). NDA 22081, held by Gilead. Ambrisentan.
As of Nov 14, 2026, NDA 22081 (Letairis), held by Gilead, was first approved by FDA on Jun 15, 2007, with 33 approved supplements and 0 published complete response letters.
Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability. Studies establishing effectiveness included predominantly patients with WHO Functional Class II–III symptoms and etiologies of idiopathic or heritable PAH (60%) or PAH associated with connective tissue diseases (34%).
| Oct 2, 2015 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Feb 15, 2012 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 2007 | Original applicationNew molecular entity · Priority review | Approved |
| Letairis5MG · tablet;oral | Ambrisentan | RxReference drug |
| Letairis10MG · tablet;oral | Ambrisentan | RxReference drug |
| Apr 4, 2025 | Supplement 45REMS | Approved | |
| Aug 19, 2024 | Supplement 44REMS | Approved | |
| Jun 8, 2021 | Supplement 43REMS | Approved | |
| Dec 22, 2020 | Supplement 42REMS | Approved | |
| Aug 23, 2019 | Supplement 41Labeling · Standard review | Approved | |
| Mar 28, 2019 | Supplement 39REMS | Approved | |
| Nov 30, 2018 | Supplement 40Labeling · Standard review | Approved | |
| Sep 27, 2017 | Supplement 38REMS | Approved | |
| Jul 21, 2017 | Supplement 37REMS | Approved | |
| Dec 15, 2016 | Supplement 36REMS | Approved | |
| Mar 21, 2016 | Supplement 35Manufacturing · Priority review | Approved | None posted |
| Oct 2, 2015 | Supplement 33Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2015 | Supplement 34Manufacturing · Priority review | Approved | None posted |
| Oct 29, 2014 | Supplement 32REMS | Approved | |
| Sep 26, 2014 | Supplement 28Manufacturing · Priority review | Approved | None posted |
| Jul 2, 2014 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| May 5, 2014 | Supplement 29Labeling · Standard review | Approved | |
| Jan 31, 2014 | Supplement 30REMS | Approved | |
| Aug 17, 2013 | Supplement 19REMS | Approved | |
| Jan 16, 2013 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Jan 10, 2013 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Oct 19, 2012 | Supplement 22Labeling | Approved | |
| Feb 15, 2012 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Jul 19, 2011 | Supplement 18Labeling | Approved | |
| Mar 3, 2011 | Supplement 17Labeling | Approved | |
| Oct 13, 2010 | Supplement 12Labeling | Approved | |
| Aug 24, 2010 | Supplement 16REMS | Approved | |
| Aug 5, 2009 | Supplement 10Labeling · Standard review | Approved | |
| Jul 1, 2009 | Supplement 11Labeling · Standard review | Approved | |
| May 29, 2009 | Supplement 8Labeling · Standard review | Approved | |
| Oct 8, 2008 | Supplement 4Labeling · Standard review | Approved | |
| Feb 14, 2008 | Supplement 2Labeling · Standard review | Approved | |
| Nov 29, 2007 | Supplement 1Labeling · Standard review | Approved | |
| Jun 15, 2007 | Original applicationNew molecular entity · Priority review | Approved |
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
