Quick answers
- What is Selexipag used for?
- The FDA-approved label (Uptravi, Actelion Pharmaceuticals US, Inc., May 28, 2026) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Selexipag have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Selexipag?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Selexipag been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Selexipag?
- 3 companies list prescription products of Selexipag in the FDA NDC Directory, including Actelion Pharmaceuticals US, Inc., Zydus Lifesciences Limited and Zydus Pharmaceuticals USA Inc..
What Selexipag is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Uptravi, Actelion Pharmaceuticals US, Inc., effective May 28, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet, coated · Injection, powder, for solution |
|---|---|
| Route | Oral · Intravenous |
| Prescription products | 27 in the FDA NDC Directory |
| Brand names | Uptravi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Actelion Pharmaceuticals US, Inc.11 products
- Zydus Lifesciences Limited8 products
- Zydus Pharmaceuticals USA Inc.8 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA207947 UPTRAVI | Actelion | December 21, 2015 | 9, latest May 23, 2026 2026: Labeling · 2026: Efficacy · 2021: Labeling |
| NDA214275 UPTRAVI | Actelion | July 29, 2021 | 1, latest May 23, 2026 2026: Labeling |
Generic approvals (1)
- ANDA214302Zydus Lifesciences · December 21, 2022
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Uptravi, Actelion Pharmaceuticals US, Inc., effective May 28, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →