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Icosapent Ethyl

Generic Name
Icosapent Ethyl
Brand Names
Vascepa, Vazkepa
Drug Type
Small Molecule
Chemical Formula
C22H34O2
CAS Number
86227-47-6
Unique Ingredient Identifier
6GC8A4PAYH

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

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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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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