Vascepa

Product manufactured by Bryant Ranch Prepack

Application Nr Approved Date Route Status External Links
NDA202057 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Vascepa ® (Icosapent Ethyl) Is Indicated: As An Adjunct To Maximally Tolerated Statin Therapy To Reduce The Risk Of Myocardial Infarction, Stroke, Coronary Revascularization, And Unstable Angina Requiring Hospitalization In Adult Patients With Elevated Triglyceride (Tg) Levels (≥ 150 Mg/dl) And Established Cardiovascular Disease Or Diabetes Mellitus And 2 Or More Additional Risk Factors For Cardiovascular Disease. As An Adjunct To Diet To Reduce Tg Levels In Adult Patients With Severe (≥ 500 Mg/dl) Hypertriglyceridemia. Limitations Of Use: The Effect Of Vascepa On The Risk For Pancreatitis In Patients With Severe Hypertriglyceridemia Has Not Been Determined. Vascepa Is An Ethyl Ester Of Eicosapentaenoic Acid (Epa) Indicated: As An Adjunct To Maximally Tolerated Statin Therapy To Reduce The Risk Of Myocardial Infarction, Stroke, Coronary Revascularization, And Unstable Angina Requiring Hospitalization In Adult Patients With Elevated Triglyceride (Tg) Levels (≥ 150 Mg/dl) And Established Cardiovascular Disease Or Diabetes Mellitus And 2 Or More Additional Risk Factors For Cardiovascular Disease. ( 1 ) As An Adjunct To Diet To Reduce Tg Levels In Adult Patients With Severe (≥ 500 Mg/dl) Hypertriglyceridemia. ( 1 ) Limitations Of Use: The Effect Of Vascepa On The Risk For Pancreatitis In Patients With Severe Hypertriglyceridemia Has Not Been Determined. ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Icosapent Ethyl

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