FDA Accepts Unicycive Therapeutics' NDA Resubmission for Oxylanthanum Carbonate

The U.S. FDA has accepted Unicycive Therapeutics' resubmitted New Drug Application (NDA) for oxylanthanum carbonate (OLC), an oral phosphate binder for hyperphosphatemia in chronic kidney disease patients on dialysis. The agency designated it a Class II review, setting a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027, following a previous Complete Response Letter.