For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 217656, held by Zydus Lifesciences. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 217656 (Icosapent Ethyl), held by Zydus Lifesciences, was first approved by FDA on Apr 20, 2023, 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 on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) 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 on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 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
