Richter And Allergan Announce FDA Has Extended The Review Period For Cariprazine To September 2015

BUDAPEST, Hungary and DUBLIN, June 16, 2015 /PRNewswire/ -- Gedeon Richter Plc and Allergan Plc (NYSE: AGN) today announced that the U.S. Food and Drug Administration (FDA) notified the companies that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug Application (NDA) for cariprazine. Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Logo- http://photos.prnewswire.com/prnh/20150612/222796LOGO The FDA has determined that a recent response to an FDA question about the cariprazine NDA is a "major amendment",...