Alkermes has announced that FDA has advised Alkermes that it will not be able to complete its review of the New Drug Application (NDA) for Aristada (aripiprazole lauroxil) for the treatment of schizophrenia by the Prescription Drug User Fee Act (PDUFA) action date of 22 August 2015. FDA indicated that this delay was expected to be brief, measured in terms of weeks, but could not confirm specific timing. FDA also indicated that no additional data or information is required from Alkermes at this time.
“We are confident in the AristadaA program and our NDA submission, and we will work closely with the FDA as they complete their review,” said Elliot Ehrich, Chief Medical Officer of Alkermes. “We look forward to bringing Aristada to market as a potential new treatment option to help address the significant unmet medical needs of patients living with schizophrenia.”
