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U.S. Department of Health and Human Services


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Darbepoetin alfa Product Approval Information - Licensing Action 7/19/02

Proper name: Darbepoetin alfa
Tradename: Aranesp
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: Treatment of anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitantly administered chemotherapy
Approval Date: 7/19/2002
Type of submission: Biologics license supplement


Approval Letter (PDF)

Labeling (PDF)

Patient Package Insert (PDF)