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 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 |