Treats pulmonary arterial hypertension (PAH, WHO Group I). NDA 204410, held by Actelion. Macitentan.
As of Nov 14, 2026, NDA 204410 (Opsumit), held by Actelion, was first approved by FDA on Oct 18, 2013, with 23 approved supplements and 0 published complete response letters.
OPSUMIT is an endothelin receptor antagonist (ERA) indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults to reduce the risks of disease progression and hospitalization for PAH. 1.1 Pulmonary Arterial Hypertension
| Feb 28, 2025 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Oct 18, 2013 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Opsumit10MG · tablet;oral | Macitentan | RxReference drug |
| Apr 2, 2025 | Supplement 31REMS | Approved | |
| Feb 28, 2025 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Dec 12, 2024 | Supplement 30REMS | Approved | |
| Apr 11, 2024 | Supplement 27REMS | Approved | |
| May 26, 2023 | Supplement 24Labeling · Standard review | Approved | |
| Feb 1, 2023 | Supplement 23REMS | Approved | |
| Oct 25, 2021 | Supplement 22Labeling · Standard review | Approved | |
| May 26, 2021 | Supplement 21Labeling · Standard review | Approved | |
| Apr 8, 2020 | Supplement 20REMS | Approved | |
| Jun 10, 2019 | Supplement 19REMS | Approved | None posted |
| Apr 23, 2019 | Supplement 17Labeling · Standard review | Approved | |
| Feb 1, 2019 | Supplement 18REMS | Approved | |
| Oct 16, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Aug 25, 2017 | Supplement 13REMS | Approved | |
| Mar 21, 2017 | Supplement 11Labeling · Standard review | Approved | |
| Oct 21, 2016 | Supplement 9Labeling · Standard review | Approved | |
| Jun 15, 2016 | Supplement 8Labeling · Standard review | Approved | |
| Mar 22, 2016 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Feb 22, 2016 | Supplement 7REMS | Approved | |
| Feb 17, 2016 | Supplement 6Labeling · Standard review | Approved | |
| Nov 17, 2015 | Supplement 2REMS | Approved | |
| Apr 30, 2015 | Supplement 3Labeling · Standard review | Approved | |
| May 20, 2014 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Oct 18, 2013 | Original applicationNew molecular entity · Standard 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
