Reduces elevated sitosterol and campesterol levels. ANDA 210673, held by Sciegen Pharms. Ezetimibe.
As of Nov 13, 2026, ANDA 210673 (Ezetimibe), held by Sciegen Pharms, was first approved by FDA on Oct 23, 2020, with 2 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 23, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ezetimibe10MG · tablet;oral | Ezetimibe | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 6, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Oct 17, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 23, 2020 | Original application | Approved | None posted |
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
