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As of Nov 13, 2026, NDA 213260 (Atorvaliq), held by Cmp Dev LLC, was first approved by FDA on Feb 1, 2023, with 1 approved supplement and 1 published complete response letter.
First approved: Feb 1, 2023
Review: Standard
Supplements approved: 1
Complete response letters: 1
What It's For
From the FDA-approved label (Indications and Usage)
ATORVALIQ is indicated:
To reduce the risk of: o Myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD. o MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD. o Non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: o Adults with primary hyperlipidemia.
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
