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news.QRxPharma has commenced new drug application (NDA) filing procedure with the US Food and Drug Administration (FDA) for MoxDuo IR as a treatment for moderate to severe acute pain.
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The NDA filling is backed by complete clinical and manufacturing program of MoxDuo IR.
The NDA filing will help QRxPharma to register the drug in Europe, Australia, Canada and elsewhere.
In Study 022, the drug has showed reduction in respiratory depression which will support the company for submitting European marketing authorisation application (MAA) in 2012.
QRxPharma managing director and CEO John Holaday said in just four years, they have successfully moved MoxDuo IR through clinical trials and NDA submission by demonstrating its effectiveness and safety.
"The Company is on track for product approval and sales in 2012 when MoxDuo IR is to be launched into the US pain market," Holaday said.