Trials & Filings

Forest, Richter Schizophrenia Drug Gets CRL

Agency wants trial data

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Forest Laboratories and Gedeon Richter Plc. received a Complete Response Letter (CRL) from the FDA regarding the 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 CRL, the FDA acknowledged that cariprazine demonstrated effectiveness in the treatment of schizophrenia and mania associated with bipolar disorder, but declared that more information, including ad...

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