Quick answers
- What is Ambrisentan used for?
- The FDA-approved label (Letairis, Gilead Sciences, Inc., June 22, 2026) says: “Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Ambrisentan have a boxed warning?
- Yes. The FDA label for Letairis has a boxed warning (“WARNING: EMBRYO-FETAL TOXICITY”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Ambrisentan?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Ambrisentan been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Ambrisentan?
- 13 companies list prescription products of Ambrisentan in the FDA NDC Directory, including Actavis Pharma, Inc., Sigmapharm Laboratories, LLC and Mylan Pharmaceuticals Inc..
What Ambrisentan is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Letairis is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in adult patients: To improve exercise ability and delay clinical worsening. In combination with tadalafil to reduce the risks of disease progression and hospitalization for worsening PAH, and to improve exercise ability […]. …
— FDA label: Letairis, Gilead Sciences, Inc., effective June 22, 2026. Read the full label on DailyMed →
The FDA has 13 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. Its heading: WARNING: EMBRYO-FETAL TOXICITY
. Read it on the full label →
12 of 13 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 26 in the FDA NDC Directory |
| Brand names | Letairis |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| ambrisentan 10 mg tablet, film coated | Generic | $7.24 per tablet |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
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.
- Actavis Pharma, Inc.2 products
- Sigmapharm Laboratories, LLC2 products
- Mylan Pharmaceuticals Inc.2 products
- Zydus Lifesciences Limited2 products
- Golden State Medical Supply, Inc.2 products
- Aurobindo Pharma Limited2 products
- Gilead Sciences, Inc.2 products
- Zydus Pharmaceuticals USA Inc.2 products
- Cipla USA Inc.2 products
- Quallent Pharmaceuticals Health LLC2 products
- A-S Medication Solutions2 products
- Apotex Corp.2 products
- Sun Pharmaceutical Industries, Inc.2 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 |
|---|---|---|---|
| NDA022081 LETAIRIS | Gilead | June 15, 2007 | 33, latest April 4, 2025 2025: REMS · 2024: REMS · 2021: REMS |
Generic approvals (8)
- ANDA208252Watson Labs Inc · March 28, 2019
- ANDA208441Mylan · March 28, 2019
- ANDA210058Zydus Pharms · March 28, 2019
- ANDA210784Sun Pharm · March 28, 2019
- ANDA208354Sigmapharm Labs LLC · April 10, 2019
- ANDA210715Cipla · April 26, 2019
- ANDA210701Apotex · May 19, 2022
- ANDA216531Aurobindo Pharma · July 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
| RxCUI (RxNorm) | 722116, 722120, 722122, 722124 |
|---|---|
| SPL set ID of the quoted label | 725d4e73-6c83-477a-adc6-0ae4a133a844 |
| FDA labels (SPL) | 13 |
| FDA applications | NDA022081, 8 ANDA |
| Active ingredients (FDA) | AMBRISENTAN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Letairis, Gilead Sciences, Inc., effective June 22, 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 →