Sunovion Pharma said that Latuda is included in the atypical antipsychotic class of drugs.
FDA Center for Drug Evaluation and Research Division of Psychiatry Products director Thomas Laughren said that some patients do not respond well to certain types of drug therapy, so it is important to have multiple treatment options available.
Four six-week controlled studies of adults with schizophrenia demonstrated the effectiveness and safety of Latuda.
In the trials, patients treated with Latuda had fewer symptoms of schizophrenia than those taking an inactive pill (placebo).