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Nexlizet FDA Approval History

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

FDA Approved: Yes (First approved February 26, 2020)
Brand name: Nexlizet
Generic name: bempedoic acid and ezetimibe
Dosage form: Tablets
Company: Esperion Therapeutics
Treatment for: High Cholesterol, Familial Heterozygous

Nexlizet (bempedoic acid and ezetimibe) is an adenosine triphosphate-citrate lyase (ACL) inhibitor and a cholesterol absorption inhibitor combination indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or established atherosclerotic cardiovascular disease who require additional lowering of LDL-C.

Development timeline for Nexlizet

Feb 26, 2020Approval FDA Approves Nexlizet (bempedoic acid and ezetimibe) 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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