For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 216811, held by Ascent Pharms Inc. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 216811 (Icosapent Ethyl), held by Ascent Pharms Inc, was first approved by FDA on Feb 16, 2024, 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.
| Feb 16, 2024 | Original application | Approved | None posted |
| Dec 7, 2023 | Original application | Approved | None posted |
| Icosapent Ethyl500MG · capsule;oral | Icosapent Ethyl | Rx |
| 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
