Lurasidone Approved For Bipolar I Depression For Children Aged 10-17

The U.S. Food and Drug Administration (FDA) recently approved Latuda (lurasidone HCI) for the treatment of depression associated with bipolar I disorder in children aged 10 to 17. The new drug application for Lurasidone was filed by Sunovion Pharmaceuticals, Inc.

Previously, Latuda received FDA approval as a monotherapy treatment for adults with depressive episodes associated with bipolar depression, as well as for treatment of schizophrenia in both adolescents and adults. The FDA’s approval was based on data from the drug’s Phase III study of children and adolescents with bipolar depression, which found that the participants experienced statistically . . .