Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

FDA Approves Vraylar for Schizophrenia in Adults

Allergan plc news release; 2017 Nov 13

Allergan plc has announced that the US Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar is also approved in the US in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder. Allergan plc is headquartered in Dublin, Ireland.

Dosage/administration: For schizophrenia, Vraylar should be administered once daily, with or without food. The starting dose is 1.5 mg/day; recommended dose is 1.5 mg to 6 mg/day.

Adverse effects: The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) for patients taking Vraylar for schizophrenia were extrapyramidal symptoms and akathisia.


Allergan receives FDA approval for use of Vraylar (cariprazine) in the maintenance treatment of schizophrenia. [news release] Dublin, Ireland: Allergan plc. November 13, 2017. Accessed November 14, 2017.

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