Cariprazine regulatory update

Allergan (formerly Actavis plc) and Gedeon said FDA extended the PDUFA date by 3 months to September for a resubmitted NDA for cariprazine to treat schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. The specific PDUFA date is not disclosed. According to the partners, FDA determined that a recent response to a question from the agency about the application is a “major amendment.” ...