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FDA Approves Monthly Injection Uzedy for Bipolar I Treatment

10/15/2025

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Story summary
  • The FDA approved Uzedy (risperidone) as a once-monthly extended-release injection for maintenance treatment of bipolar I disorder in adults.
  • The approval aims to address treatment gaps and improve adherence for bipolar I disorder with severe symptoms.
  • Clinical studies showed the injection prolonged time to relapse versus placebo.
  • Adverse events included injection site nodules and weight gain.
  • Teva's Chris Fox stated Uzedy builds on its success in treating schizophrenia.