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Alkermes PLC submits New Drug Application to FDA for Aripiprazole Lauroxil for treatment of Schizophrenia

Monday, 25 Aug 2014 07:00am EDT 

Alkermes PLC:Submits a New Drug Application to the U.S. Food and Drug Administration for approval of aripiprazole lauroxil for the treatment of schizophrenia.Data submitted as part of this NDA include the positive results from the pivotal phase 3 study assessing the efficacy and safety of aripiprazole lauroxil, in which aripiprazole lauroxil demonstrated significant improvements in schizophrenia symptoms, compared to placebo.