BioCentury
ARTICLE | Company News

FDA to discuss QRxPharma's MoxDuo

May 17, 2013 1:32 AM UTC

FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet on July 17 to discuss an NDA from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The PDUFA date is Aug. 26. Last June, the agency 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). ...