US FDA sets PDUFA date for QRxPharma's resubmitted MoxDuo NDA

Australia-based QRxPharma (ASX: QRX) says that the US Food and Drug Administration has set August 26, 2013, as the Prescription Drug User Fee Act (PDUFA) date for action on the company's resubmitted MoxDuo (morphine and oxycodone) New Drug Application.

Last year, the FDA issued a complete response letter on the NDA for MoxDuo, which is partnered with Actavis US generics drugmaker Actavis (NYSE: ACT) for commercialization in the US market, calling for additional information regarding the safety and effectiveness of the combination drug (The Pharma Letter June 29, 2012). QRxPharma says that, pending a successful review of the NDA, a product launch is anticipated before the end of this calendar year.

"We are pleased that the FDA has formally accepted our resubmitted MoxDuo NDA," said John Holaday, managing director and chief executive of QRxPharma. "We expect the Advisory Committee meeting to be scheduled between late June and late July and will update shareholders once formal notification has been received," added Dr Holaday.