FDA Approves Vanda Schizophrenia Drug for Bipolar I Disorder

FDA Decision Tracker_Taylor Tieden

Pictured: A scientist works behind an FDA sign/Taylor Tieden for BioSpace

The FDA approved 55 new drugs and 34 cell and gene therapies in 2023. But it’s not always good news that companies have to deliver to their stakeholders; the year also had its fair share of Complete Response Letters.

As we embark on 2024, BioSpace is committed to keeping you up-to-date on all the FDA’s actions in this FDA Decision Tracker.  


April 2

Product: Vanda Pharmaceuticals’ Fanapt

Indication: Bipolar I disorder

Vanda Pharmaceuticals’ Fanapt, originally approved in 2009 for schizophrenia, is now authorized to treat manic or mixed episodes in adults with bipolar I disorder.

Tuesday’s approval is backed by data from a Phase III trial comprising around 400 patients with a history of bipolar I disorder who are currently suffering from a manic episode. Treatment with Fanapt led to significantly…
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