Amgen Receives Complete Response Letter For Extended Dosing Of Aranesp(R) For Patients With Chronic Kidney Disease And Anemia

... Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter, commonly referred to as an "approvable" letter, for Aranesp(R) (darbepoetin alfa) de novo once every-two-week and maintenance once-monthly dosing regimens for chronic kidney disease (CKD) patients with anemia not on dialysis. [click link for full article] ...