For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 217844, held by Onesource. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 217844 (Icosapent Ethyl), held by Onesource, was first approved by FDA on Sep 22, 2023, with 0 approved supplements and 0 published complete response letters.
Icosapent ethyl capsules are indicated: as an adjunct to diet to reduce 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 |
|---|---|---|---|
| Sep 22, 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
