Forest Laboratories and Gedeon Richter Plc announced that the FDA has 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.

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In the complete response letter, the FDA stated that cariprazine has demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder. However, more information, including additional clinical trial data, will be required.

The safety and efficacy of cariprazine was studied in a clinical trial program of more than 2,700 patients.

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