Actavis Resubmits NDA for Cariprazine
Actavis plc and Gedeon Richter, a pharmaceutical company headquartered in Budapest, Hungary, report that the US Food and Drug Administration (FDA) has acknowledged receipt of Actavis’ new drug application (NDA) resubmission for its atypical antipsychotic cariprazine, a potent dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors. The Prescription Drug User Fee Act (PDUFA) date is expected to be in the second quarter of 2015.
Cariprazine, an investigational drug, is an atypical antipsychotic for the treatment of patients with schizophrenia and for patients with manic or mixed episodes associated with bipolar I disorder. The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2,700 patients. In addition, cariprazine is being investigated for the treatment of bipolar depression and as adjunctive treatment for major depressive disorder in adults. Cariprazine is protected by a composition-of-matter patent that expires in 2027.