The U.S. Food and Drug Administration (FDA) granted approval for NEXLIZET, a prescription oral tablet that contains 180 mg bempedoic acid and 10 mg ezetimibe. The product is marketed by Esperion Therapeutics, Inc. and is identified by NDA 211617.
The original submission (submission number 1) was classified as a Type 1/4 new molecular entity and new combination, with a standard review priority. FDA label, approval letter, and review documents were released in February and April 2020.
Subsequent supplemental submissions have provided labeling updates. A supplemental submission (number 18) in September 2023 added a new label and approval letter. Another supplemental submission (number 28) in July 2025 added further labeling documents.
NEXLIZET is listed as a human prescription drug, administered orally, and falls under the pharmacologic classes of ATP‑citrate lyase inhibitor and dietary cholesterol absorption inhibitor.
Regulatorische Updates18. Sept. 2026•3 Min. Lesezeit
FDA approves NEXLIZET (bempedoic acid and ezetimibe) – NDA211617
The FDA approved NEXLIZET, an oral tablet combining bempedoic acid 180 mg and ezetimibe 10 mg, under NDA 211617. The approval and subsequent labeling updates are documented.
Zusammengestellt vom Pharmacountry-Team · Quelle: FDA.gov
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