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Zerenex submitted in August
October 8, 2013
By: Gil Roth
President, Pharma & Biopharma Outsourcing Association
Keryx Biopharmaceuticals‘ NDA for Zerenex (ferric citrate coordination complex) has been accepted for filing by the FDA. The acceptance indicates that the FDA has determined that the application is sufficiently complete to permit a substantive review. The company’s NDA, submitted on August 7, 2013, seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis. ...
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