
Vanda Pharmaceuticals secured approval from the US Food and Drug Administration (FDA) for Fanapt (iloperidone) tablets for the acute treatment of manic or mixed episodes linked with bipolar I disorder in adults. Fanapt, an atypical antipsychotic agent initially approved for schizophrenia in 2009, offers flexible dosing and a well-established safety profile. The approval expands treatment options for the complex condition, benefiting patients and healthcare providers. The decision was supported by a pivotal study demonstrating Fanapt's efficacy over placebo, with notable improvement observed as early as Week 2 of treatment. Vanda CEO emphasized the significance of the milestone and the company's commitment to addressing unmet medical needs.
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