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U.S. Department of Health and Human Services


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Anakinra Product Approval Information - Licensing Action

Proper name: Anakinra
Tradename: Kineret
Manufacturer: Amgen, Inc, Thousand Oaks, CA, License #1080
Indication for Use: Reduction in signs and symptoms of moderately to severely active rheumatoid arthritis, in patients 18 years of age or older who have failed one or more disease modifying antirheumatic drugs (DMARDS)
Approval Date: 11/14/2001
Type of submission: Biologics license application


Approval Letter - (PDF)

Label - (PDF)

Patient Label - (PDF)