FDA Approves Iloperidone (Fanapt®) For Bipolar I Disorder

The U.S. Food and Drug Administration (FDA) has approved Vanda Pharmaceuticals, Inc.’s Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt®;is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009.

The approval of Fanapt®;for the acute treatment of adults with manic or mixed episodes associated with bipolar I disorder was based on a pivotal study randomizing approximately 400 participants. The primary endpoint measured in Week 4 of treatment was assessed . . .