Lowers the risk of major adverse cardiovascular events (cardiovascular death, myocardial…. NDA 211616, held by Esperion Theraps Inc. Bempedoic Acid.
As of Nov 14, 2026, NDA 211616 (Nexletol), held by Esperion Theraps Inc, was first approved by FDA on Feb 21, 2020, with 8 approved supplements and 0 published complete response letters.
NEXLETOL is indicated: to reduce the risk of major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke, or coronary revascularization) in adults at increased risk for these events who are unable to take recommended statin therapy (including those not taking a statin). as an adjunct to diet and exercise, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
| Nov 21, 2025 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| Mar 22, 2024 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Mar 22, 2024 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Feb 21, 2020 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Nexletol180MG · tablet;oral | Bempedoic Acid | RxReference drug |
| Jan 9, 2026 | Supplement 26Labeling · Standard review | Approved | |
| Nov 21, 2025 | Supplement 24Efficacy (new indication or use) · Standard review | Approved | |
| Jul 21, 2025 | Supplement 23Labeling · Standard review | Approved | |
| Jul 21, 2025 | Supplement 22Labeling · Standard review | Approved | |
| Mar 22, 2024 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Mar 22, 2024 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Sep 20, 2023 | Supplement 14Labeling · Standard review | Approved | |
| Feb 21, 2020 | Original applicationNew molecular entity · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
