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FDA NDA · NDA211616

NEXLETOL

bempedoic acid

Sponsor: ESPERION THERAPS INC

APPLICATION
NDA211616
TYPE
NDA
ORIGINAL APPROVAL
2020-02-21
LATEST ACTION
2026-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NEXLETOL · ReferencePrescription
BEMPEDOIC ACID 180MG · TABLET · ORAL

Approval history

2026-01-09Labeling · Supplement 26 · standard — Label ↗AP
2025-11-21Efficacy · Supplement 24 · standard — Letter ↗AP
2025-07-21Labeling · Supplement 22 · standard — Letter ↗AP
2025-07-21Labeling · Supplement 23 · standard — Letter ↗AP
2024-03-22Efficacy · Supplement 12 · standard — Label ↗AP
2024-03-22Efficacy · Supplement 13 · standard — Label ↗AP
2023-12-13Labeling · Supplement 15 · standard — Label ↗AP
2023-09-20Labeling · Supplement 14 · standard — Letter ↗AP
2020-02-21Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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