For severe (≥500 mg/dL) hypertriglyceridemia. ANDA 209437, held by Apotex. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 209437 (Icosapent Ethyl), held by Apotex, was first approved by FDA on Jun 30, 2021, with 1 approved supplement 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 30, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Icosapent Ethyl1GM · capsule;oral | Icosapent Ethyl | Rx |
| Sep 17, 2026 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jun 30, 2021 | Original application | Approved | None posted |
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
