Amgen's Epogen
Executive Summary
FDA approves labeling change broadening the target hematocrit range to be achieved in chronic renal failure patients from 30%- 33% to 30%-36%. Amgen said the wider range will make dosing of Epogen (epoetin alfa) "more practical," but that it "will have little sales impact in the short term." Other labeling changes include clarification of dose titration guidelines, updated safety data and quality-of-life information