Vraylar Approval History

• FDA approved: Yes (First approved September 17th, 2015)
• Brand name: Vraylar
• Generic name: cariprazine
• Dosage form: Capsules
• Company: Allergan, Inc.
• Treatment for: Schizophrenia, Bipolar Disorder

Vraylar (cariprazine) is a dopamine D₃/D₂ receptor partial agonist atypical antipsychotic for the acute treatment of manic or mixed episodes associated with bipolar I disorder and for the treatment of schizophrenia.

Development History and FDA Approval Process for Vraylar

Date	Article
Sep 17, 2015	FDA Approves Vraylar (cariprazine) for Schizophrenia and Bipolar Disorder
Jun 16, 2015	Richter And Allergan Announce FDA Has Extended The Review Period For Cariprazine To September 2015
Jan 20, 2015	Richter and Actavis Announce Positive Phase III Results for Cariprazine in the Prevention of Relapse in Patients with Schizophrenia
Jan  6, 2015	Actavis and Gedeon Richter Announce FDA Receipt of NDA Resubmission for Cariprazine
Nov 21, 2013	Forest Laboratories and Gedeon Richter Receive Complete Response Letter for Cariprazine
Nov 28, 2012	Forest Laboratories Submits New Drug Application for Cariprazine for the Treatment of Both Schizophrenia and Manic or Mixed Episodes Associated with Bipolar I Disorder

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