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Keryx Assigned PDUFA Date for Zerenex

Goal date set for June 7, 2014

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Keryx Biopharmaceuticals, Inc. was assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 7, 2014 by the FDA for its NDA for Zerenex (ferric citrate coordination complex). The company’s drug candidate is for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis.

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