Further FDA delay for QRxPharma's MoxDuo

29 August 2013

Australia-based QRxPharma (ASX: QRX) has received a complete response letter from the US Food and Drug Administration regarding its New Drug Application for MoxDuo (morphine and oxycodone) for the treatment of moderate to severe acute pain.

The issue of the CRL allows time to submit and evaluate further information required for the US FDA to fully consider the respiratory safety advantages of MoxDuo from Study 022, the company noted.

Will refile NDA before end of year

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