For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 219156, held by Xiamen LP Pharm Co. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 219156 (Icosapent Ethyl), held by Xiamen LP Pharm Co, was first approved by FDA on Aug 6, 2025, with 0 approved supplements and 0 published complete response letters.
Icosapent ethyl capsules 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 6, 2025 | 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
