FDA receives Actavis' NDA resubmission for cariprazine

Jan 6 2015

Actavis plc (NYSE: ACT) and Gedeon Richter Plc. today announced that the U.S. 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.

"We believe the resubmission of the cariprazine NDA includes the necessary data to address FDA's comments and continue the review of this innovative treatment option," said David Nicholson, Actavis Senior Vice President, Global Brands R&D. "We are committed to the mental health community and this promising treatment option to address patients' medical needs."

"We are pleased that the resubmission procedure occurred according to the originally established timeline," added Dr. István Greiner, Research Director of Gedeon Richter Plc. "We continue to provide all the necessary clinical and regulatory support to Actavis to bring cariprazine to the market."