FDA Approves Fanapt for Acute Treatment of Bipolar I Disorder

April 3, 2024

DENVER, Colo., Apr 03, 2024 (247marketnews.com)- Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) today announced that the U.S. Food and Drug Administration approved Fanapt® (iloperidone), an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009, tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

“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.

Dr. Polymeropoulos continued, “Today’s announcement marks a significant step forward for one of Vanda’s leading franchises and underscores the effectiveness of our strategy in pursuing innovative therapies that address high unmet medical needs to improve the lives of patients. With this as our foundation, we have established a resilient business, with a diverse product pipeline, a history of revenue growth and strong financial position. We remain focused on providing critical medicines to patients across the world while creating sustainable, long-term value.”

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