The FDA has approved Fanapt tablets as an atypical antipsychotic agent for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Vanda Pharmaceuticals Inc. announced the approval, stating that Fanapt has been prescribed for schizophrenia since 2009. The approval provides a new treatment option for managing bipolar I disorder, with data from a phase 3 study showing greater improvement in symptom severity with Fanapt compared to placebo at week 2 and week 4. The safety profile of Fanapt in this study was similar to previous studies in treating schizophrenia in adults.
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FDA approves Fanapt for bipolar disorder in adults
