Icosapent Ethyl

For severe (≥500 mg/dL) hypertriglyceridemia. ANDA 209457, held by Hikma. Icosapent Ethyl.

As of Nov 15, 2026, ANDA 209457 (Icosapent Ethyl), held by Hikma, was first approved by FDA on May 21, 2020, with 0 approved supplements and 0 published complete response letters.

First approved: May 21, 2020
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Icosapent ethyl is indicated:

as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Limitations of Use The effect of icosapent ethyl 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

Date	Submission	Status	Documents
May 21, 2020	Original application	Approved	Letter

Products

2 strengths and forms


Icosapent Ethyl1GM · capsule;oral	Icosapent Ethyl	Rx
Icosapent Ethyl500MG · capsule;oral	Icosapent Ethyl	Rx

Identifiers

Application: ANDA 209457
Drugs@FDA: Overview at FDA
Company: Hikma

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