$KERX: Keryx receives notification of PDUFA date extension for Zerenex (18.92 +0.35)
Co announced that the FDA has extended the initial Prescription Drug User Fee Act (PDUFA) goal date for its review of the Company's New Drug Application (NDA) seeking marketing approval of Zerenex (ferric citrate) by three months. The new PDUFA goal date is September 7, 2014. The notification letter from the FDA states that the Company's recent submission, in response to a Chemistry, Manufacturing and Controls (CMC) section information request from the FDA, included substantial revisions to the CMC section of the NDA. The FDA considered the submission to be a major amendment to the NDA and is extending the goal date by three months to provide time for a full review of the submission.
"We believe that we have sufficiently responded to the questions that we have received to date and will work with the FDA to answer any additional questions that they may have in order to complete their review of the Zerenex NDA," commented Ron Bentsur, Chief Executive Officer of Keryx. "Our commercial team remains focused on preparing for the potential launch of Zerenex later in the year.
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