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Chronic Kidney Failure

Amgen Announces Updates to the U.S. Prescribing Information for ESAs

Published in Health Business Week, November 23rd, 2007

Amgen (NASDAQ:AMGN) announced that it has updated the Aranesp(R) (darbepoetin alfa) and EPOGEN(R)/PROCRIT(R) (Epoetin alfa) package inserts in collaboration with the U.S. Food and Drug Administration (FDA) and Johnson and Johnson Pharmaceutical Research & Development (J&JPRD). The changes to the labeling include modifications to the boxed warnings, additional language in the INDICATIONS AND USAGE section, addition of an oncology study to the WARNINGS section, and clarification of the hemoglobin range for chronic renal failure (CRF) patients in the DOSAGE AND ADMINISTRATION section.

The Company also announced that it has developed a comprehensive clinical study...

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