Prescription medicine
Epoprostenol Brand names: Veletri; first approved as Flolan
Epoprostenol (Veletri) is a prescription medicine with an FDA approval on record since 1995. FDA's NDC Directory lists it from 3 generic labelers.
- Generic listed
Check it at the source: the epoprostenol FDA label on DailyMed (effective November 28, 2022, Actelion Pharmaceuticals US, Inc.); the NDA 20444 record on Drugs@FDA; every epoprostenol label on DailyMed.
Highlights of the record
FDA label of November 28, 2022; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity.
Forms and strengths
- 0.5 mg/10ml
- 1.5 mg/10ml
Injection (powder) (lyophilized) for solution.
On the market
- Earliest approval on file
- September 20, 1995 Flolan, Glaxosmithkline Llc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 4 first April 23, 2008; 3 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 3 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 15, 2027 Veletri injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2021 0 Class I among all firms' recalls; latest July 29, 2021
- FAERS reports
- 13,014 through July 30, 2026
What is epoprostenol used for?
From the label: indications and usageVELETRI is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases. VELETRI is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise capacity. Studies establishing effectiveness included predominantly patients with NYHA Functional Class III–IV symptoms and etiologies of idiopathic or heritable PAH or PAH associated with connective tissue diseases.
Conditions named in the indications of epoprostenol's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Prostacycline Vasodilator.
Source: FDA drug label (Veletri), Actelion Pharmaceuticals US, Inc., effective November 28, 2022 (SPL set df502787-46ec-4dd1-a2c0-be90f6d95a5d), via openFDA; the full label on DailyMed
Is there a generic for epoprostenol (Veletri)?
The FDA approved the first generic epoprostenol on April 23, 2008. 4 generic applications are approved; 3 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists epoprostenol from 3 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 2 patents for Veletri injection, the last expiring on March 15, 2027. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1995 earliest approval on file
- 2008 first generic approved
- 2027 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has epoprostenol been recalled?
The FDA's Enforcement Report lists 3 recalls naming epoprostenol since 2021: 0 Class I (the most serious), 3 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 29, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility |
| February 10, 2021 | Class II | Teva Pharmaceuticals USA | Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the epoprostenol label say about other medicines?
The epoprostenol label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name epoprostenol. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Digoxin | drug interactions | In a pharmacokinetic substudy in patients with congestive heart failure receiving furosemide or digoxin in whom therapy with epoprostenol was initiated, apparent oral clearance values for furosemide (n=23) and digoxin (n=30) were decreased by 13% and 15%, respectively, on the second day of therapy and had returned to … |
| Furosemide | drug interactions | In a pharmacokinetic substudy in patients with congestive heart failure receiving furosemide or digoxin in whom therapy with epoprostenol was initiated, apparent oral clearance values for furosemide (n=23) and digoxin (n=30) were decreased by 13% and 15%, respectively, on the second day of therapy and had returned to … |
Source: FDA drug label (Veletri), Actelion Pharmaceuticals US, Inc., effective November 28, 2022 (SPL set df502787-46ec-4dd1-a2c0-be90f6d95a5d), via openFDA; the full label on DailyMed
What do FAERS reports show for epoprostenol?
The FDA Adverse Event Reporting System holds 13,014 reports that list epoprostenol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,685 are coded as a death and 8,725 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as epoprostenol?
2 other medicines are given the same way (intravenous) and in the same FDA class as epoprostenol or labeled mainly for the same use (pulmonary arterial hypertension), the same class first. Pulmonary arterial hypertension lists all 11 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Treprostinil | Pulmonary arterial hypertension | 4 labelers | n/a | No current entry |
| Selexipag | Pulmonary arterial hypertension | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Other prostacycline vasodilators
- the pharmacologic class, with prices and generics
- Epoprostenol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other