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As User Fee Date Nears, Australia’s QRxPharma Moves To POC For MoxDuo CR Formulation; Secures Actavis As Partner

This article was originally published in PharmAsia News

Executive Summary

The company looks to position its dual-opioid combination against Purdue Pharma’s OxyContin.

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Australia's QRxPharma Files NDA With U.S. FDA For Combo Opioid That Looks Safer Than Single Compounds

Sydney-headquartered QRxPharma filed in late July its MoxDuo IR (morphine/oxycodone) NDA with U.S. FDA for the treatment of moderate to severe acute pain. The NDA was submitted under the 505(b)(2) pathway, which allows for historical data because the two components of the dual opioid are already approved. Interestingly, the morphine and oxycodone combo appears to be safer than the two single compounds

Aspen's Acquisition of Sigma For APAC Expansion Comes At Time Of Generics Uncertainty In Australia

TOKYO - South African firm Aspen appears on track to finalize its months-long acquisition attempt of Australia's Sigma Pharmaceuticals, shifting away from its original offer for a full acquisition to a leaner deal in which Aspen will gain Sigma's pharmaceutical division

QRxPharma Makes Pain Connection By Teaching Old Drugs New Tricks

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