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QRxPharma Ltd Reports Positive Meeting With FDA On MOXDUO


Tuesday, 8 Oct 2013 06:25pm EDT 

QRxPharma Ltd announced the results of its meeting on October 3, 2013, with the United States Food and Drug Administration (FDA) to discuss the Company's MOXDUO New Drug Application (NDA). At the end-of-review meeting, the FDA provided the Company with a more complete understanding of their requirements for submission of the revised NDA and data validation documentation. The FDA reaffirmed that the safety and efficacy of MOXDUO are not at question, and that the Company‚Äôs presentation of the totality of the respiratory safety advantages to an Advisory Committee of experts would help guide their final decision. Accordingly, the FDA encouraged QRxPharma to submit its validated data and updated NDA. The Agency will then schedule an Advisory Committee meeting preceding a Prescription Drug User Fee Act (PDUFA) date six months following NDA resubmission. The revised NDA is the basis for recommencing the regulatory approval process for MOXDUO for the treatment of moderate to severe acute pain, a USD2.5 billion segment of the USD8 billion spent annually on prescription opioids in the United States. The revised NDA also serves as the regulatory foundation for submitting MOXDUO for approval in Europe, Australia, Canada and other markets in the upcoming months. Assuming approval, the Company anticipates that MOXDUO will be launched in the United States during 2014. 

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