US FDA rejects new drug application from Richter

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The US Food and Drug Administration (FDA) has rejected Hungary-based pharmaceutical producer Gedeon Richter’s “New Drug Application” to distribute its schizophrenia antipsychotic cariprazine in North America, requesting more detailed information, including additional data from clinical trials.

Forest Research Institute president Dr. Marco Taglietti noted in his response, however, that “the unmet medical need for schizophrenia and bipolar disorder remains high. We are committed to pursuing novel treatment options like cariprazine to address patient needs. Forest and Gedeon Richter plan to meet with the FDA in the very near future to discuss the complete response letter and define a path forward.”

Forest Laboratories, which owns the rights to market cariprazine in the US and Canada, submitted the application to the FDA in November 2012.

Richter communications director Zsuzsa Beke told national news service MTI that the request would likely not entail further clinical trials involving cariprazine nor would the expected date of introduction of drug to the North American market be jeopardized.

Beke also stated that no date has been determined for the meeting between Richter, Forest Laboratories and the FDA.

Richter announced earlier that in the event of regulatory authority approval, cariprazine would be launched in the US market in the first quarter of 2014 at the soonest and in the European market in 2015/early 2016.

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