![Erythropoiesis-stimulating agents / Pharmacology / Food and Drug Administration / Growth factors / Amgen / Darbepoetin alfa / Erythropoietin / Biologic / Center for Biologics Evaluation and Research / Medicine / Biology / Pharmaceutical sciences Erythropoiesis-stimulating agents / Pharmacology / Food and Drug Administration / Growth factors / Amgen / Darbepoetin alfa / Erythropoietin / Biologic / Center for Biologics Evaluation and Research / Medicine / Biology / Pharmaceutical sciences](https://www.pdfsearch.io/img/4800a13f028eee706f31696bd4eafe5a.jpg)
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City Rockville / / Company Amgen Incorporated / FACP / / Currency USD / / Event FDA Phase / / Facility Rockville Pike / / IndustryTerm drug substanceand drug product / final formulated product / manufacturing facilities / treatment of anemia associatedwith chronic renal failure / manufacturing / proposed introductory advertising / final stability protocol / Final printed advertising / manufacturing pro&d / drug product / stability protocol / licensed biological products / Final formulated drug product / / MedicalCondition chronic renal failure / anemia / / MedicalTreatment hemodialysis / dialysis / / Organization FACP Director Office / Food and Drug Administration / DEPARTMENT OF HEALTH / Center for Biologics Evaluation and Research / / Person Morstyn / / Position Director / / Product Aranesp / Page4 / September13 / / ProvinceOrState Maryland / California / / Technology pharmacokinetics / final stability protocol / stability protocol / antibodies / PDF / dialysis / /
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