FDA Accepts Resubmission of NDA for Oxylanthanum Carbonate for Chronic Kidney Disease, Sets PDUFA Date

The U.S. Food and Drug Administration (FDA) has accepted Unicycive Therapeutics' resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.