Quick answers
- What is Macitentan used for?
- The FDA-approved label (Opsumit, Actelion Pharmaceuticals US, Inc., April 11, 2025) says: “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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Macitentan have a boxed warning?
- Yes. The FDA label for Opsumit has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Macitentan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Macitentan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Macitentan?
- 15 companies list prescription products of Macitentan in the FDA NDC Directory, including Apotex Corp., Amneal Pharmaceuticals NY LLC and Sandoz Inc.
What Macitentan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
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. …
— FDA label: Opsumit, Actelion Pharmaceuticals US, Inc., effective April 11, 2025. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
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.
This label has a boxed warning. Read it on the full label →
14 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated · Tablet |
|---|---|
| Route | Oral |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Opsumit |
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.
- Apotex Corp.1 product
- Amneal Pharmaceuticals NY LLC1 product
- Sandoz Inc1 product
- Alembic Pharmaceuticals Inc.1 product
- Zydus Pharmaceuticals USA Inc.1 product
- ANI Pharmaceuticals, Inc.1 product
- Laurus Labs Limited1 product
- Sun Pharmaceutical Industries, Inc.1 product
- Actelion Pharmaceuticals US, Inc.1 product
- Mylan Pharmaceuticals Inc.1 product
- Alembic Pharmaceuticals Limited1 product
- Novugen Pharma (USA) LLC1 product
- Aurobindo Pharma Limited1 product
- Teva Pharmaceuticals, Inc.1 product
- Torrent Pharmaceuticals Limited1 product
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 |
|---|---|---|---|
| NDA204410 OPSUMIT | Actelion | October 18, 2013 | 23, latest April 2, 2025 2025: REMS · 2025: Efficacy · 2024: REMS |
Generic approvals (12)
- ANDA211224Zydus Lifesciences · April 6, 2021
- ANDA211198Aurobindo Pharma Ltd · April 18, 2023
- ANDA211195Apotex · January 9, 2024
- ANDA211107Torrent · August 5, 2024
- ANDA211128Alembic · August 18, 2025
- ANDA211136Msn · August 20, 2025
- ANDA211123Sun Pharm · August 26, 2025
- ANDA211120Laurus · November 5, 2025
- ANDA211026Lepu Pharm · December 3, 2025
- ANDA211161Mylan · December 3, 2025
- ANDA211000Amneal · June 8, 2026
- ANDA211187Teva Pharms USA Inc · June 8, 2026
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
| RxCUI (RxNorm) | 1442137, 1442143 |
|---|---|
| SPL set ID of the quoted label | 1e484a50-55db-4b85-8c57-6cd1b0353abd |
| FDA labels (SPL) | 14 |
| FDA applications | NDA204410, 12 ANDA |
| Active ingredients (FDA) | MACITENTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Opsumit, Actelion Pharmaceuticals US, Inc., effective April 11, 2025; 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 →