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For severe (≥500 mg/dL) hypertriglyceridemia. ANDA 218899, held by Qilu. Icosapent Ethyl.
As of Nov 15, 2026, ANDA 218899 (Icosapent Ethyl), held by Qilu, was first approved by FDA on Nov 20, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Nov 20, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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. Icosapent ethyl capsules are an ethyl ester of eicosapentaenoic acid (EPA) 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.
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