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

This article was originally published in PharmAsia News

Executive Summary

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

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