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VASCEPA (nda202057)- (1GM,500MG)

ICOSAPENT ETHYL AMARIN PHARMS
1GM,500MG
Yes Yes
2033-Jun-28 2017-Jul-26
None 2015-Jul-26
None No
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 o established cardiovascular disease or o 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.
9 0 8
Total Other Developers 12
Drugs with Suitability No
1GM ** ** Down - 8
500MG ** ** Up - 6
NDA Sales Available Total Generic Sales Available
Yes 7
ANDA No Generic Co Manufacturer Name Operations Manufacturer Address Country
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