FDA to review QRxPharma's MoxDuo

FDA accepted for review an NDA for MoxDuo IR morphine/oxycodone from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) to treat moderate to severe acute pain. The PDUFA date is Aug. 26. The company said it expects FDA to schedule an advisory committee meeting in late June or early July to discuss the NDA. Last June, FDA issued a complete response letter requesting clarity on the safety and effectiveness of the immediate-release combination of oxycodone and morphine (see BioCentury Extra, June 28, 2012). ...