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Reduces elevated sitosterol and campesterol levels. NDA 21445, held by Organon. Ezetimibe.
As of Nov 14, 2026, NDA 21445 (Zetia), held by Organon, was first approved by FDA on Oct 25, 2002, with 28 approved supplements and 0 published complete response letters.
First approved: Oct 25, 2002
Review: Standard
Supplements approved: 28
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
ZETIA 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 daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
