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August 27, 2013
19:26 EDTQRXPYQRxPharma receives complete response letter from FDA
QRxPharma announced the United States FDA has issued a complete response letter regarding the company's Moxudo New Drug Application for the treatment of moderate to severe acute pain. 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, inclusive of the additional information and analysis as requested by the FDA. QRxPharma anticipates a new Prescription Drug User Fee Act date in Q2, preceded by an advisory committee meeting.
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