Darbepoetin alfa

Proper name: Darbepoetin alfa
Tradename: Aranesp
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: Treatment of anemia associated with chronic renal failure, including patients on dialysis and patients not on dialysis
Approval Date: 9/17/2001
Type of submission: Biologics license application

Approval Letter (Text), (PDF)

Label (PDF), (Text)

Patient Package Insert (PDF)

CMC Review (PDF)

Medical Officer (PDF)

Clinical Pharm (PDF)

Statistical (PDF)

Immunogenicity (PDF)

Toxicology (PDF)
 

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Updated: January 21, 2004

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