New drug application for Richter antipsychotic agent submitted by US partner
US-based Forest Laboratories has submitted a new drug application to the US Food and Drug Administration for cariprazine, an antipsychotic agent developed by Hungarian peer Gedeon Richter, Richter said on Wednesday. Forest Laboratories submitted the application for cariprazine for the treatment of both schizophrenia and manic or mixed episodes associated with Bipolar I Disorder. Cariprazine is licensed to Forest Laboratories in the US and Canada. The application for the treatment of schizophrenia includes the result of three positive trials in more than 1,700 patients. The application for the treatment of manic or mixed episodes associated with Bipolar I Disorder includes results from three positive placebo-controlled trials in over 1,000 patients. Richter shares opened up 0.25% at HUF 35,650 on Wednesday.
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