Uzedy FDA Approval History
Last updated by Judith Stewart, BPharm on May 2, 2023.
FDA Approved: Yes (First approved April 28, 2023)
Brand name: Uzedy
Generic name: risperidone
Dosage form: Extended-Release Injectable Suspension
Company: Teva Pharmaceuticals and MedinCell
Treatment for: Schizophrenia
Uzedy (risperidone) is a long-acting injectable atypical antipsychotic indicated for the treatment of schizophrenia in adults.
- Risperidone is an atypical antipsychotic thought to work in the treatment of schizophrenia through dopamine Type 2 (D2) and serotonin Type 2 (5HT)2 receptor antagonism.
- Risperidone was first approved under the brand name Risperdal as an oral tablet formulation in 1993, followed by Risperdal oral solution in 1996, Risperdal M-Tab orally disintegrating tablets in 2003 (now discontinued), and Risperdal Consta long-acting intramuscular injection in 2003. Additional extended-release injectable formulations were approved under the brand name Perseris (for subcutaneous use once-monthly) in 2018, and Rykindo (for intramuscular use every two weeks) in 2023.
- Uzedy is administered by subcutaneous injection once every month or once every two months.
- The Uzedy product label carries a Boxed Warning for increased risk of death in elderly patients with dementia-related psychosis. Warnings and precautions associated with Uzedy include increased incidence of cerebrovascular adverse reactions in elderly patients with dementia-related psychosis; neuroleptic malignant syndrome; tardive dyskinesia; metabolic changes; hyperprolactinemia; orthostatic hypotension and syncope; leukopenia, neutropenia, and agranulocytosis; potential for cognitive and motor impairment; seizures; and priapism.
- Common adverse reactions with risperidone include parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain. Common injection site reactions with Uzedy include pruritus and injection site nodules.
Development timeline for Uzedy
| Date | Article |
|---|---|
| Apr 28, 2023 | Approval FDA Approves Uzedy (risperidone) Extended-Release Injectable Suspension for the Treatment of Schizophrenia in Adults |
Further information
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