Vascepa

Lowers the risk of myocardial infarction, stroke, coronary revascularization, and…. NDA 202057, held by Amarin Pharms. Icosapent Ethyl.

As of Nov 14, 2026, NDA 202057 (Vascepa), held by Amarin Pharms, was first approved by FDA on Jul 26, 2012, with 18 approved supplements and 0 published complete response letters.

First approved: Jul 26, 2012
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (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.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below


Dec 13, 2019	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 26, 2012	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


Vascepa1GM · capsule;oral	Icosapent Ethyl	RxReference drug
Vascepa500MG · capsule;oral	Icosapent Ethyl	RxReference drug

All 19 submissions, including labeling and manufacturing supplements


Mar 16, 2026	Supplement 58Manufacturing	Approved	Letter Label
Dec 13, 2019	Supplement 35Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 16, 2017	Supplement 19Manufacturing · Standard review	Approved	Label
Jan 28, 2016	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 25, 2016	Supplement 16Manufacturing · Standard review	Approved	None posted
Oct 2, 2015	Supplement 14Manufacturing · Standard review	Approved	None posted
Aug 4, 2015	Supplement 13Manufacturing · Standard review	Approved	None posted
Jun 23, 2015	Supplement 12Manufacturing · Standard review	Approved	Label
Oct 16, 2014	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 14, 2014	Supplement 10Manufacturing · Standard review	Approved	None posted
Jul 28, 2014	Supplement 7Manufacturing · Standard review	Approved	None posted
Feb 26, 2014	Supplement 8Manufacturing · Standard review	Approved	None posted
Feb 13, 2014	Supplement 6Manufacturing · Standard review	Approved	Letter Label
Nov 25, 2013	Supplement 9Labeling · Standard review	Approved	Letter Label
Apr 19, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Apr 12, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Mar 20, 2013	Supplement 2Manufacturing	Approved	Label
Jan 31, 2013	Supplement 1Manufacturing · Standard review	Approved	Letter
Jul 26, 2012	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 202057
Drugs@FDA: Overview at FDA
Company: Amarin

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters