FDA approves Fanapt for bipolar disorder in adults

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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