Allergan Receives FDA Approval For Label Expansion Of VRAYLAR - Quick Facts

(RTTNews) - Allergan plc (AGN) announced the U.S. 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 U.S. in adults for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder.

The efficacy of VRAYLAR in the maintenance treatment of schizophrenia was based on an up to 72-week, multinational, double-blind, placebo-controlled, randomized withdrawal study in the prevention of relapse in adult patients with schizophrenia.