Ferric citrate regulatory update

FDA approved an NDA from Keryx for ferric citrate to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. FDA contraindicated the drug in patients with iron overload syndromes such as hemochromatosis. The drug's label bears a warning that patients' iron levels should be monitored while on the therapy due to the risk of iron overload.

Keryx plans to launch the oral ferric iron-based phosphate binder within 12 weeks under a new brand name. The company said FDA rescinded approval of the brand name Zerenex, but noted a brand name is not a prerequisite for the launch of an approved drug. Keryx said it will disclose the price of the drug "in the coming weeks." ...