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FDA NDA · NDA211617

NEXLIZET

bempedoic acid and ezetimibe

Sponsor: ESPERION THERAPS INC

APPLICATION
NDA211617
TYPE
NDA
ORIGINAL APPROVAL
2020-02-26
LATEST ACTION
2026-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NEXLIZET · ReferencePrescription
BEMPEDOIC ACID 180MG, EZETIMIBE 10MG · TABLET · ORAL

Approval history

2026-01-09Labeling · Supplement 31 · standard — Label ↗AP
2025-11-21Efficacy · Supplement 29 · standard — Letter ↗AP
2025-07-21Labeling · Supplement 28 · standard — Letter ↗AP
2025-07-21Labeling · Supplement 27 · standard — Letter ↗AP
2024-03-22Efficacy · Supplement 16 · standard — Letter ↗AP
2024-03-22Efficacy · Supplement 17 · standard — Letter ↗AP
2023-12-13Labeling · Supplement 19 · standard — Letter ↗AP
2023-09-20Labeling · Supplement 18 · standard — Letter ↗AP
2020-02-26Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Label ↗AP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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