Vraylar FDA Approval History

Last updated by Judith Stewart, BPharm on Dec 21, 2022.

FDA Approved: Yes (First approved September 17, 2015)
Brand name: Vraylar
Generic name: cariprazine
Dosage form: Capsules
Company: AbbVie Inc.
Treatment for: Schizophrenia, Bipolar Disorder, Major Depressive Disorder

Vraylar (cariprazine) is an atypical antipsychotic for the treatment of schizophrenia, bipolar I disorder, and major depressive disorder.

• Vraylar is indicated for the:
  • treatment of schizophrenia in adults
  • acute treatment of manic or mixed episodes associated with bipolar I disorder in adults
  • treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults
  • adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults.
• Vraylar is thought to work through a combination of partial agonist activity at central dopamine D₂ and serotonin 5-HT_1A receptors and antagonist activity at serotonin 5-HT_2A receptors.
• Vraylar is administered orally, once daily, with or without food.
• The Vraylar product label carries a Boxed Warning for an increased risk of mortality in elderly patients with dementia-related psychosis, and an increased risk of suicidal thoughts and behaviors in pediatric and young adult patients.
• Warnings and precautions associated with Vraylar include cerebrovascular adverse reactions in elderly patients with dementia-related psychosis, neuroleptic malignant syndrome, tardive dyskinesia, late-occurring adverse reactions due to long half-life, metabolic changes, leukopenia, neutropenia, agranulocytosis, orthostatic hypotension and syncope, seizures, and potential for cognitive and motor impairment.
• Common adverse reactions in patients treated for schizophrenia include extrapyramidal symptoms and akathisia.
  Common adverse reactions in patients treated for bipolar mania include extrapyramidal symptoms, akathisia, dyspepsia, vomiting, somnolence, and restlessness.
  Common adverse reactions in patients treated for bipolar depression include nausea, akathisia, restlessness, and extrapyramidal symptoms.
  Common adverse reactions in patients receiving adjunctive treatment for MDD include akathisia, restlessness, fatigue, constipation, nausea, insomnia, increased appetite, dizziness, and extrapyramidal symptoms. 

Development timeline for Vraylar

Further information

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