**Path Forward for Moxduo NDA Resubmission Clarified by QRxPharma and FDA**
January 16, 2013
QRxPharma Limited (ASX: QRX and OTCQX: QRXPY) announced today a significant development in their pursuit of approval for Moxduo immediate release. Following discussions with the United States Food and Drug Administration (FDA), the necessary steps for resubmission of the New Drug Application (NDA) have been clearly defined.
The FDA’s feedback provides QRxPharma a structured path forward, detailing specific requirements needed for approval. This includes additional data that demonstrate the drug’s safety and efficacy for its intended use.
The collaborative engagement with the FDA marks an important step in moving closer to making Moxduo available in the market. Moxduo is an innovative combination opioid therapy aimed at providing effective pain relief with a reduced risk of adverse side effects compared to traditional opioid treatments.
Biotech investors should note this progress as it highlights the potential for Moxduo to meet an unmet need in the pain management landscape. The market opportunity is sizeable given the ongoing demand for safer opioid therapies.
For further insight into the NDA process and what this means for QRxPharma’s strategy, [learn more here](http://www.drugs.com/new-drug-applications.html) or visit the [Drugs.com link](http://www.drugs.com/nda/moxduo_130116.html?utm