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QRxPharma - NDA resubmitted

Wednesday, Mar 06 2013 by

Mar 06th 2013 - Edison Investment Research today published a report on QRxPharma entitled "NDA Resubmitted". In summary, the report says:

QRxPharma has resubmitted its NDA for Q8003/MoxDuo IR for moderate-to-severe acute pain, putting it on track to undergo an Advisory Committee review in late Q2 and potentially obtain approval in Q3 this year. The filing contains additional data requested by the FDA following the complete response letter (CRL) received last year. Separate filings are expected in Canada, the EU and Australia in H1 of CY13.




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