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FDA accepts Supplemental New Drug Application for Incyte 's Jakafi (ruxolitinib) and Priority Review Granted


Tuesday, 5 Aug 2014 07:30am EDT 

Incyte Corp:Announced that U.S. FDA has accepted for filing supplemental New Drug Application (sNDA) for ruxolitinib as potential treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea.Says sNDA includes results from RESPONSE Phase III trial, which were recently presented at 2014 American Society of Clinical Oncology (ASCO) annual meeting.RESPONSE was conducted under Special Protocol Assessment (SPA) from FDA.Prescription Drug User Fee Act (PDUFA) date for sNDA for ruxolitinib is set for Dec. 5. 

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