FDA label
What is Livalo used for?
Livalo contains pitavastatin. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label says: “LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia; Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).”
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Livalo, tablet, film coated
Indications and Usage, quoted from the label by Kowa Pharmaceuticals America, Inc. (NDA022363). Cross-references to other label sections are left out.
LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in:
- Adults with primary hyperlipidemia.
- Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).
Source: DailyMed label, set id 44dcbf97-99ec-427c-ba50-207e0069d6d2, version 12, effective March 31, 2026. NDC 66869-104, one of 3 listings for this product.
Questions
What is Livalo used for?
The FDA label says: “LIVALO is indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in: Adults with primary hyperlipidemia; Adults and pediatric patients aged 8 years and older with heterozygous familial hypercholesterolemia (HeFH).”
What drug class is Livalo?
FDA lists pitavastatin in the HMG-CoA Reductase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.
More on Livalo
- Is Livalo a controlled substance?Federal schedule
- Generic for LivaloFDA Orange Book
- What is Pitavastatin used for?FDA label uses
- Is Pitavastatin a controlled substance?Federal schedule
- Generic for ZypitamagFDA Orange Book
- Statins listFDA drug class
- NDC 66869-104Livalo NDC record
- NDC 66869-204Livalo NDC record
- NDC 66869-404Livalo NDC record