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Sunovion Pharmaceuticals Inc. is a U.S subsidiary Sumitomo Dainippon Pharma Co., Ltd.
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Important Safety Information
INDICATIONS
LATUDA is indicated for treatment of adult and adolescent patients (13 to 17 years) with schizophrenia. LATUDA is indicated for monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar I disorder (bipolar depression) and adjunctive treatment with lithium or valproate in adult patients with bipolar depression.

IMPORTANT SAFETY INFORMATION FOR LATUDA

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS


Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. LATUDA is not approved for the treatment of patients with dementia-related psychosis.


Suicidal Thoughts and Behaviors

Antidepressants increased the risk of suicidal thoughts and behavior in pediatric and young adults in short-term studies. Closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors.