FDA accepts supplemental new drug application for Vraylar (cariprazine)

Allergan

8 March 2017 - Application seeks to expand Vraylar label to include phase 3 clinical data for the maintenance treatment of schizophrenia.

Allergan today announced that the U.S. FDA has accepted for filing the company's supplemental new drug application for VRAYLAR (cariprazine), seeking the addition of new clinical data evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia to the current product label.

Read Allergan press release

Michael Wonder

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Michael Wonder

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Medicine , US , Submission