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Treats pulmonary arterial hypertension (PAH, WHO Group I). NDA 214275, held by Actelion. Selexipag.
As of Nov 14, 2026, NDA 214275 (Uptravi), held by Actelion, was first approved by FDA on Jul 29, 2021, with 1 approved supplement and 0 published complete response letters.
First approved: Jul 29, 2021
Review: Standard
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
UPTRAVI is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension (PAH, WHO Group I): In adults to delay disease progression and reduce the risk of hospitalization for PAH. In pediatric patients aged 2 years and older. UPTRAVI reduces NT-proBNP and is expected to delay disease progression and reduce the risk of hospitalization for PAH. 1.1 Pulmonary Arterial Hypertension Adult Patients
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
