[Skip navigation]FDA Logo links to FDA home page
Center for Drug Evaluation and Research, U.S. Food and Drug AdministrationU.S. Food and Drug AdministrationCenter for Drug Evaluation and Research
  HHS Logo links to Department of Health and Human Services website

FDA Home Page | CDER Home Page | CDER Site Info | Contact CDER | What's New @ CDER

horizonal rule
CDER Home About CDER Drug Information Regulatory Guidance CDER Calendar Specific Audiences CDER Archives
 
Powered by Google
 

 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)

 

Back to Top     Back to Index

Updated: September 25, 2003

horizonal rule