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Treats pulmonary arterial hypertension (PAH, WHO Group I). NDA 207947, held by Actelion. Selexipag.
As of Nov 14, 2026, NDA 207947 (Uptravi), held by Actelion, was first approved by FDA on Dec 21, 2015, with 9 approved supplements and 0 published complete response letters.
First approved: Dec 21, 2015
Review: Standard
Supplements approved: 9
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
