FDA Approves Risperidone Injectable for Bipolar I Disorder
- The FDA has expanded the approved use of Uzedy, a risperidone extended-release injectable suspension, to include the treatment of adults with Bipolar I disorder.Previously, it was used for...
- * Addresses Unmet Need: Experts believe this approval addresses a meaningful gap in treatment options for bipolar I disorder, as adherence to oral medications can be a...
- Source: The facts comes from a news release by Teva Pharmaceuticals, dated October 10, 2025.A link to the original release is provided.
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Uzedy (risperidone) Receives Expanded FDA Approval
The FDA has expanded the approved use of Uzedy, a risperidone extended-release injectable suspension, to include the treatment of adults with Bipolar I disorder.Previously, it was used for schizophrenia.
Key Points:
* Addresses Unmet Need: Experts believe this approval addresses a meaningful gap in treatment options for bipolar I disorder, as adherence to oral medications can be a challenge.
* Long-Acting Injectable: Uzedy is a long-acting injectable, which is seen as a key innovation in CNS (central nervous system) therapeutics.
* Common Side Effects: Common side effects reported in clinical trials include headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increase, pain in extremity, and dry mouth.
* Positive Reception: Clinicians and the manufacturer (Medincell,through Teva Pharmaceuticals) are optimistic about the availability of this new treatment option.
Source: The facts comes from a news release by Teva Pharmaceuticals, dated October 10, 2025.A link to the original release is provided.