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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: Allergan plc
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-HT1A receptors and antagonist activity at serotonin 5-HT2A 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

Dec 16, 2022Approval U.S. FDA Approves Vraylar (cariprazine) as an Adjunctive Treatment for Major Depressive Disorder
May 28, 2019Approval FDA Approves Expanded Use of Vraylar (cariprazine) in the Treatment of Bipolar Depression
Nov 13, 2017Approval Allergan Receives FDA Approval for Vraylar (cariprazine) in the Maintenance Treatment of Schizophrenia
Sep 17, 2015Approval FDA Approves Vraylar (cariprazine) for Schizophrenia and Bipolar Disorder
Jun 16, 2015Richter And Allergan Announce FDA Has Extended The Review Period For Cariprazine To September 2015
Jan 20, 2015Richter and Actavis Announce Positive Phase III Results for Cariprazine in the Prevention of Relapse in Patients with Schizophrenia
Jan  6, 2015Actavis and Gedeon Richter Announce FDA Receipt of NDA Resubmission for Cariprazine
Nov 21, 2013Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Cariprazine
Nov 28, 2012Forest Laboratories Submits New Drug Application for Cariprazine for the Treatment of Both Schizophrenia and Manic or Mixed Episodes Associated with Bipolar I Disorder

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.