Aristada aripiprazole lauroxil regulatory update

Alkermes said FDA will not be able to complete the review of the biotech’s NDA for Aristada aripiprazole lauroxil to treat schizophrenia by the Aug. 22 PDUFA date. The company said FDA indicated the delay was expected “to be brief, measured in terms of weeks, but could not confirm specific timing.” Alkermes said FDA did not require additional information or data. The product is an extended-release, once-monthly, injectable formulation of aripiprazole using the company’s LinkeRx technology. ...