Allergan Eyes Vraylar Label Expansion, FDA Accepts sNDA
Allergan AGN announced that the FDA has accepted its supplemental new drug application (sNDA) for approval of its schizophrenia drug, Vraylar (cariprazine) for an expanded patient population. The sNDA is seeking approval of Vraylar for the treatment of adults with major depressive episodes related to bipolar I disorder. Notably, Vraylar is already approved in the United States and the EU for acute therapy of manic or mixed episodes associated with bipolar I disorder as well as for schizophrenia. […]