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QRxPharma Ltd Receives Complete Response Letter From FDA Regarding MOXDUO NDA

Tuesday, 27 Aug 2013 07:24pm EDT 

QRxPharma Ltd announced the United States Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the Company's MOXDUO New Drug Application (NDA) for the treatment of moderate to severe acute pain. The Company confirmed the issuance of the CRL was to allow time to submit and evaluate further information required for the FDA to fully consider the respiratory safety advantages of MOXDUO from Study 022. With the issue of the CRL, in order to maintain FDA review, the Company is required to resubmit its NDA. QRxPharma plans to complete its refiling in Q4 2013, inclusive of the additional information and analysis as requested by the FDA. QRxPharma anticipates a new PDUFA (Prescription Drug User Fee Act) date in Q2 2014, preceded by an Advisory Committee meeting. The Company will also have an "end of review" meeting with the FDA in the coming weeks that is currently being scheduled. 

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