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ARTICLE | Company News

QRxPharma expects delay for MoxDuo review

June 27, 2013 12:45 AM UTC

QRxPharma Ltd. (ASX:QRX; OTCQX:QRXPY) said it expects FDA to delay an upcoming advisory committee meeting and PDUFA date for MoxDuo IR morphine/oxycodone to treat moderate to severe acute pain. The company said it expects the delay because of plans to submit to FDA next month a revised analysis of Phase III results. The revision corrects an error in the time points at which some data were collected.

FDA's Anesthetic and Analgesic Drug Products Advisory Committee is scheduled to meet July 17 to discuss an NDA for the immediate-release combination of oxycodone and morphine, which has an Aug. 26 PDUFA date. ...