FDA committee to discuss QRxPharma's MoxDuo IR

FDA's Anesthetic and Analgesic Drug Products Advisory Committee will meet on April 22 to discuss a resubmitted NDA from QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The PDUFA date is May 25. The resubmitted NDA contains an audit of data from the company's Phase III Study 022 trial. FDA issued a complete response letter for the immediate-release combination of oxycodone and morphine in August (see BioCentury Extra, Aug. 28, 2013). ...