Darbepoetin alfa
Product Approval Information - Licensing Action
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 (Text),
(PDF)
Labeling (PDF)
Patient Package Insert (PDF)
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Updated: September 25, 2003 |