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FDA Agrees to Review Hyperphosphatemia Drug, Zerenex (Ferric Citrate)
Treatment aimed at dialysis patients with kidney disease (October 8)
The FDA has accepted for filing a New Drug Application (NDA) for Zerenex (ferric citrate coordination complex, Keryx Biopharmaceuticals). The acceptance indicates the determination by the FDA that the application is sufficiently complete to permit a substantive review.
The NDA, submitted Aug. 7, seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels (hyperphosphatemia) in patients with chronic kidney disease (CKD) on dialysis.
Zerenex is also in phase II development in the U.S. for the management of elevated phosphorus and iron deficiency in anemic patients with stage 3 to stage 5 non–dialysis-dependent CKD.[Source: Keryx Biopharmaceuticals; October 8, 2013.]