FDA Approves Uzedy for Bipolar I Disorder Expansion
- Key Takeaway: The FDA has approved an expanded use for Uzedy (risperidone), a long-acting injectable medication, to now include the maintenance treatment of adults with bipolar I disorder.
- * Medication: Uzedy (risperidone) - an extended-release injectable suspension.
Here’s a summary of the news article:
Key Takeaway: The FDA has approved an expanded use for Uzedy (risperidone), a long-acting injectable medication, to now include the maintenance treatment of adults with bipolar I disorder. It was previously approved for schizophrenia.
Here’s a breakdown of the details:
* Medication: Uzedy (risperidone) – an extended-release injectable suspension.
* Dosage: Available in 50mg, 75mg, and 100mg doses, administered once monthly via subcutaneous injection.
* Use: Can be used alone (monotherapy) or with lithium or valproate (adjunctive therapy).
* Basis for Approval: Existing clinical data on Uzedy, combined with data from previously approved risperidone formulations for bipolar I disorder.
* Company: Teva Pharmaceuticals.
* Quote: Teva executive Chris Fox highlights the potential of Uzedy to address unmet needs and treatment gaps for those with bipolar I disorder.