FDA accepts Keryx NDA for Zerenex
This article was originally published in Scrip
Executive Summary
The US FDA has accepted Keryx Biopharmaceuticals' new drug application (NDA) for Zerenex (ferric citrate coordination complex) under a "substantive," or 12-month standard review as a treatment for elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease (CKD) on dialysis.