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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


Letter- Darbepoetin alfa (Aranesp), Amgen, Incorporated
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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 / /

SocialTag