Forest Laboratories, Gedeon Richter Receive CRL from FDA Regarding NDA for Cariprazine

-- Forest Laboratories

and Gedeon Richter Plc. announced that the U.S. Food and Drug Administration issued a complete response letter regarding the New Drug Application (NDA) for cariprazine, an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. In the complete response letter, the FDA acknowledged that cariprazine clearly demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, the Agency indicated more information, including additional clinical trial data, would be needed. “Given the complex pharmacokinetics and metabolism of cariprazine, we believe this request was made to better define the