> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Esperion Therapeutics Plans NDA for Cholesterol Lowering Agent
- URL: https://www.fdaweb.com/esperion-therapeutics-plans-nda-for-cholesterol-lowering-agent/
- Published: 2017-03-20T12:00:00.000Z
- Updated: 2026-09-14T22:12:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138238

Esperion Therapeutics says it is planning to file in mid-2019 an NDA for bempedoic acid based on FDA confirmation that the product’s development program is adequate to support approval of an LDL-C lowering indication. The submission would follow successful completion of the firm’s global pivotal Phase 3 program. “The proposed product label would include specific language for use of bempedoic acid as an adjunct to maximally tolerated statin therapy in patients with hypercholesterolemia, specifically those at high cardiovascular disease (CVD) risk with atherosclerotic cardiovascular disease (ASCVD) and/or heterozygous familial hypercholesterolemia (HeFH) who require additional LDL-C lowering,” the company says.