Vanda Pharmaceuticals’ Fanapt receives FDA approval

Vanda Pharmaceuticals announced that the U.S. Food and Drug Administration has approved Fanapt 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. “Manic or mixed episodes associated with bipolar I disorder are highly complex conditions, which require a host of trusted options to meet individual patient needs. With over 100,000 patient years of experience, Fanapt is a familiar therapeutic agent that offers flexible dosing with a well-known safety profile. This FDA approval gives patients and service providers a new treatment option for managing bipolar I disorder,” said Mihael H. Polymeropoulos M.D., Vanda’s President, CEO and Chairman of the Board.