For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 218949, held by Aurobindo Pharma Ltd. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 218949 (Icosapent Ethyl), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 24, 2026, with 0 approved supplements and 0 published complete response letters.
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 capsules on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 24, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Icosapent Ethyl1GM · capsule;oral | Icosapent Ethyl | Rx |
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
