Darbepoetin alfa Product Approval Information - Licensing Action 9/17/01

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 (PDF)

Label (PDF)

Patient Package Insert (PDF)

CMC Review (PDF)

Medical Officer (PDF)

Clinical Pharm (PDF)

Statistical (PDF)

Immunogenicity (PDF)

Toxicology (PDF)