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Nexletol FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 27, 2021.

FDA Approved: Yes (First approved February 21, 2020)
Brand name: Nexletol
Generic name: bempedoic acid
Dosage form: Tablets
Company: Esperion Therapeutics, Inc.
Treatment for: High Cholesterol, Familial Heterozygous

Nexletol (bempedoic acid) is a first-in-class, adenosine triphosphate-citrate lyase (ACL) inhibitor for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-Cholesterol.

Development timeline for Nexletol

Feb 21, 2020Approval FDA Approves Nexletol (bempedoic acid) to Lower LDL-Cholesterol
May  5, 2019Esperion Announces U.S. FDA Acceptance of New Drug Applications (NDAs) for Both Bempedoic Acid and the Bempedoic Acid / Ezetimibe Combination Tablet for Filing and Regulatory Review
Mar 13, 2019Esperion Announces Publication of Bempedoic Acid Study 1 Results in The New England Journal of Medicine

Further information

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