QRxPharma refiles application for oxycodone, morphine combination pill Moxduo

Drug maker has sought FDA approval for Moxduo since 2011

BEDMINSTER, N.J. — QRxPharma has resubmitted its regulatory approval application for an opioid painkiller for which it has sought Food and Drug Administration approval since 2011, the company said Tuesday.

The Australian drug maker announced the resubmission of its application for Moxduo, a pill that combines oxycodone and morphine.The FDA is expected to schedule an advisory committee meeting to review the application for May 2014.

"We are confident that our refiled [new drug application] will confirm the validity of the data defining the product's respiratory safety advantages, and we are hopeful that the FDA will view them favorably in their consideration of the benefits of immediate-release Moxduo as a therapeutic option for the millions of patients who suffer from acute pain," QRxPharma CEO and managing director John Holaday said.

 

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