Overview
Omega-3-acid ethyl esters are prescription drugs that contain eicosapentaenoic acid-ethyl ester (EPA) and docosahexaenoic acid-ethyl ester (DHA) that are used in combination with changes in diet to lower triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. Omega-3-acid ethyl esters are currently marketed in the US, EU, and many other regions under the brand name Lovaza.
Background
Omega-3-acid ethyl esters are prescription drugs that contain eicosapentaenoic acid-ethyl ester (EPA) and docosahexaenoic acid-ethyl ester (DHA) that are used in combination with changes in diet to lower triglyceride levels in adults with severe (≥ 500 mg/dL) hypertriglyceridemia. Omega-3-acid ethyl esters are currently marketed in the US, EU, and many other regions under the brand name Lovaza.
Indication
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).
Associated Conditions
- Severe Hypertriglyceridemia (sHTG)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/08 | Phase 2 | Recruiting | |||
2022/03/16 | Phase 2 | Terminated | |||
2020/03/16 | Early Phase 1 | Completed | |||
2018/07/26 | Phase 2 | Active, not recruiting | |||
2017/12/29 | Phase 1 | Terminated | |||
2017/11/01 | Phase 1 | Terminated | |||
2017/06/23 | Phase 1 | Withdrawn | |||
2017/06/05 | Phase 1 | Withdrawn | |||
2017/05/30 | Phase 1 | Withdrawn | |||
2017/05/30 | Phase 1 | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Strides Pharma Science Limited | 64380-761 | ORAL | 900 mg in 1 1 | 10/1/2021 | |
| Bryant Ranch Prepack | 72162-2111 | ORAL | 1 g in 1 1 | 9/19/2023 | |
| Lifestar Pharma LLC | 70756-423 | ORAL | 1 g in 1 1 | 6/10/2022 | |
| A-S Medication Solutions | 50090-3956 | ORAL | 900 mg in 1 1 | 8/16/2017 | |
| Rebel Distributors Corp | 21695-795 | ORAL | 1 g in 1 1 | 7/24/2009 | |
| Par Pharmaceutical Inc. | 0254-3010 | ORAL | 900 mg in 1 1 | 9/25/2017 | |
| Direct_Rx | 72189-024 | ORAL | 1 g in 1 1 | 8/2/2019 | |
| U.S. Pharmaceutical Corporation | 52747-621 | ORAL | 200 mg in 1 1 | 7/13/2022 | |
| A-S Medication Solutions | 50090-3957 | ORAL | 900 mg in 1 1 | 5/18/2020 | |
| Bryant Ranch Prepack | 71335-2024 | ORAL | 1 g in 1 1 | 6/7/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Omacor Soft Capsule 1000mg | SIN14504P | CAPSULE | 1000mg | 2/11/2014 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||