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Keryx Biopharmaceuticals Inc Announces New Drug Application Submission For Zerenex For Treatment Of Hyperphosphatemia In Chronic Kidney Disease Patients On Dialysis


Thursday, 8 Aug 2013 08:30am EDT 

Keryx Biopharmaceuticals, Inc. announced that the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the Company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis. The Company's NDA submission is based primarily on the datasets derived from its Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) agreement with the FDA, and is also supported by efficacy and safety data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis. 

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13.27
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