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Vraylar FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 7, 2020.

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

Vraylar (cariprazine) is a dopamine D3/D2 receptor partial agonist atypical antipsychotic 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.

Development Timeline for Vraylar

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

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