Allergan and Gedeon Richter announced Tuesday that the FDA extended its review of a refiled marketing application for cariprazine by three months to September. The companies are seeking approval of the atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Cariprazine was originally submitted to the FDA in late 2012, although the agency issued a complete response letter in November 2013 requesting more information, including additional clinical trial data. Allergan and Gedeon Richter resubmitted information to the FDA last December. According to the companies, the agency needs more time to review because it considers a recent response to a question about the filing to be a “major amendment.”