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Vascepa FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 17, 2019.

FDA Approved: Yes (First approved July 26, 2012)
Brand name: Vascepa
Generic name: icosapent ethyl
Dosage form: Capsules
Company: Amarin Corporation plc
Treatment for: Hypertriglyceridemia, Cardiovascular Risk Reduction

Vascepa (icosapent ethyl) is an ethyl ester of eicosapentaenoic acid (EPA) indicated as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia, and as an adjunct to statin therapy to reduce the risk of of cardiovascular events.

Development Timeline for Vascepa

DateArticle
Dec 13, 2019Approval  FDA Approves Vascepa (icosapent ethyl) to Reduce Cardiovascular Risk
Jul 27, 2012Approval  Amarin Announces FDA Approval of Vascepa (icosapent ethyl) Capsules for the Reduction of Triglyceride Levels in Adult Patients With Severe Hypertriglyceridemia

Further information

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