For severe (≥ 500 mg/dL) hypertriglyceridemia. ANDA 209499, held by Dr Reddys. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 209499 (Icosapent Ethyl), held by Dr Reddys, was first approved by FDA on Mar 8, 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.
| Mar 8, 2023 | Original application | Approved | None posted |
| Aug 7, 2020 | Original application | Approved |
| Icosapent Ethyl1GM · capsule;oral | Icosapent Ethyl | Rx |
| Icosapent Ethyl500MG · 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
