Icosapent Ethyl

For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 217919, held by Humanwell Puracap. Icosapent Ethyl.

As of Nov 15, 2026, ANDA 217919 (Icosapent Ethyl), held by Humanwell Puracap, was first approved by FDA on Dec 22, 2023, with 0 approved supplements and 0 published complete response letters.

First approved: Dec 22, 2023
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Icosapent ethyl capsules are 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
Dec 22, 2023	Original application	Approved	None posted

Products

2 strengths and forms


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

Identifiers

Application: ANDA 217919
Drugs@FDA: Overview at FDA
Company: Humanwell Puracap

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