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Pharmaceuticals / Submissions and Approvals

Latuda Gets Additional FDA Approval for Treatment of Depression

March 9, 2018

The FDA approved a supplemental new drug application for Sunovion Pharmaceuticals’ Latuda (lurasidone HCl).

The drug was already approved as an antidepressant for treatment of adults with bipolar disorder. Under the sNDA, the drug is also cleared for children and adolescents aged 10 to 17 years.

The FDA approved the application based on the results of a six-week, 347-patient study, showing clinically meaningful improvement in symptoms of bipolar depression.

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