Overview
Icosapent ethyl or ethyl eicosapentaenoic acid is a synthetic derivative of the omega-3 fatty acid eicosapentaenoic acid (EPA). It is used as an adjunct therapy for severe hypertriglyceridemia (TG levels > 500 mg/dL) and to reduce the risk of cardiovascular events in certain patients with elevated triglycerides. FDA approved on July 26, 2012.
Indication
作为最大耐受他汀类药物治疗的辅助手段，以降低甘油三酯（TG）水平升高（≥150mg/dL）、已确定的心血管疾病或糖尿病以及2个或更多心血管疾病风险因素的成年患者需要住院治疗的心肌梗死、中风、冠状动脉血运重建和不稳定心绞痛的风险。
Associated Conditions
- Hospitalizations
- Severe Hypertriglyceridemias
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/04/21 | Phase 3 | Terminated | |||
2011/12/15 | Phase 3 | Completed | |||
2009/02/09 | Phase 4 | Completed | |||
2008/03/13 | Phase 2 | Completed | |||
2005/09/07 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amarin Pharma Inc. | 52937-001 | ORAL | 1000 mg in 1 1 | 2/27/2017 | |
| AvKARE | 42291-032 | ORAL | 1000 mg in 1 1 | 1/24/2024 | |
| Hikma Pharmaceuticals USA Inc. | 0054-0508 | ORAL | 1 g in 1 1 | 3/9/2023 | |
| Amarin Pharma Inc. | 52937-101 | ORAL | 1000 mg in 1 1 | 2/27/2017 | |
| XLCare Pharmaceuticals, Inc. | 72865-290 | ORAL | 1 g in 1 1 | 3/15/2024 | |
| Camber Pharmaceuticals, Inc. | 31722-298 | ORAL | 0.5 g in 1 1 | 7/9/2023 | |
| Teva Pharmaceuticals, Inc. | 0480-0127 | ORAL | 1 g in 1 1 | 8/31/2021 | |
| American Health Packaging | 60687-764 | ORAL | 1 g in 1 1 | 3/25/2024 | |
| AvKARE | 42291-046 | ORAL | 1 g in 1 1 | 12/5/2023 | |
| Dr. Reddy's Laboratories, Inc. | 43598-267 | ORAL | 1000 mg in 1 1 | 1/8/2020 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
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| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
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| No TGA approvals found for this drug. | |||||
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