Prescription medicine
Omega 3-acid ethyl esters First approved as Lovaza
Omega 3-acid ethyl esters (Lovaza) is a prescription medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 17 generic labelers, and pharmacies paid $0.171 per omega-3 ethyl esters 1 g capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the omega 3-acid ethyl esters FDA label on DailyMed (effective January 8, 2025, PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS); the NDA 21654 record on Drugs@FDA; every omega 3-acid ethyl esters label on DailyMed.
Highlights of the record
FDA label of January 8, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageOmega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia.
Forms and strengths
- 1 g
- 900 mg
Liquid-filled capsule; capsule.
On the market
- Earliest approval on file
- November 10, 2004 Lovaza, Waylis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 15 first April 7, 2014; 9 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 17 of which 17 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.171 per capsule Omega-3 ethyl esters 1 g capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 3 since 2013 0 Class I among all firms' recalls; latest April 9, 2026
- FAERS reports
- 1,919 through July 30, 2026
What is omega 3-acid ethyl esters used for?
From the label: indications and usageOmega-3-acid ethyl esters capsules are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (greater than or equal to 500 mg/dL) hypertriglyceridemia. Usage Considerations: Patients should be placed on an appropriate lipid-lowering diet before receiving omega-3-acid ethyl esters capsules and should continue this diet during treatment with omega-3-acid ethyl esters capsules. Laboratory studies should be done to ascertain that the lipid levels are consistently abnormal before instituting therapy with omega-3-acid ethyl esters capsules. […]
Conditions named in the indications of omega 3-acid ethyl esters's FDA labels, with every medicine labeled for each:
From other omega 3-acid ethyl esters labelsHigh triglycerides: Omega-3-acid ethyl esters capsules, USP are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia (HTG).
FDA pharmacologic class: Omega-3 Fatty Acid.
Source: FDA drug label (OMEGA-3-ACID ETHYL ESTERS), PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS, effective January 8, 2025 (SPL set 52d4fc86-227a-4a74-9f42-50fd184714d8), via openFDA; the full label on DailyMed
Is there a generic for omega 3-acid ethyl esters (Lovaza)?
The FDA approved the first generic omega 3-acid ethyl esters on April 7, 2014. 15 generic applications are approved; 9 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 omega 3-acid ethyl esters from 17 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2004 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for omega 3-acid ethyl esters (Lovaza)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.171 per Omega-3 ethyl esters 1 g capsule, up 2% from $0.167 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Omega-3 ethyl esters 1 g capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Omega-3 ethyl esters 1 g capsule | Generic | $0.171 per capsule | $5.13 | +2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has omega 3-acid ethyl esters been recalled?
The FDA's Enforcement Report lists 3 recalls naming omega 3-acid ethyl esters since 2013: 0 Class I (the most serious), 3 Class II, 0 Class III; 1 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 9, 2026 | Class II | The Harvard Drug Group LLC | Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells. |
| July 16, 2018 | Class II | Teva Pharmaceuticals USA | API material used in the manufacturing of the product did not receive regulatory approval prior to release. |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup: OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg may have potentially been mislabeled as one of the following drugs: SEVELAMER CARBONATE … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for omega 3-acid ethyl esters?
The FDA Adverse Event Reporting System holds 1,919 reports that list omega 3-acid ethyl esters among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 96 are coded as a death and 970 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 omega 3-acid ethyl esters?
1 other medicine is given the same way (oral) and in the same FDA class as omega 3-acid ethyl esters or labeled mainly for the same use (high triglycerides), the same class first. High triglycerides 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 (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Icosapent | High triglycerides | 18 labelers | $0.441 per capsule 1 gram capsule | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Omega 3-acid ethyl esters side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other