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Reduces elevated sitosterol and campesterol levels. ANDA 211159, held by Macleods Pharms. Ezetimibe.
As of Nov 13, 2026, ANDA 211159 (Ezetimibe), held by Macleods Pharms, was first approved by FDA on Apr 29, 2024, with 0 approved supplements and 0 published complete response letters.
First approved: Apr 29, 2024
Review: Standard
Supplements approved: 0
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
Ezetimibe is indicated:
In combination with a statin, or alone when additional low-density lipoprotein cholesterol (LDL-C) lowering therapy is not possible, as an adjunct to diet to reduce elevated LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH).
In combination with a statin as an adjunct to diet to reduce elevated LDL-C in pediatric patients 10 years of age and older with HeFH.
In combination with fenofibrate as an adjunct to diet to reduce elevated LDL-C in adults with mixed hyperlipidemia.
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
