FDA label
What is Latuda used for?
Latuda contains lurasidone. 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: “LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia; Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression); Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bip...”
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Latuda, tablet, film coated
Indications and Usage, quoted from the label by Sumitomo Pharma America, Inc. (NDA200603). Cross-references to other label sections are left out.
LATUDA is indicated for:
- Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia.
- Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression).
- Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression).
Source: DailyMed label, set id afad3051-9df2-4c54-9684-e8262a133af8, version 37, effective January 31, 2025. NDC 63402-302, one of 5 listings for this product.
Questions
What is Latuda used for?
The FDA label says: “LATUDA is indicated for: Treatment of adult and adolescent patients (13 to 17 years) with schizophrenia; Monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression); Adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bip...”
What drug class is Latuda?
FDA lists lurasidone in the Atypical Antipsychotic 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 Latuda
- Is Latuda a controlled substance?Federal schedule
- Generic for LatudaFDA Orange Book
- What is Lurasidone used for?FDA label uses
- Is Lurasidone a controlled substance?Federal schedule
- Atypical Antipsychotics listFDA drug class
- NDC 63402-302Latuda NDC record
- NDC 63402-304Latuda NDC record
- NDC 63402-306Latuda NDC record