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U.S. Department of Health and Human Services


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Etanercept Product Approval Information - Licensing Action 9/12/02

Proper name: Etanercept
Tradename: Enbrel
Manufacturer: Immunex Corp, Seattle, WA, License #1132
Revised Package Insert: Revise the Clinical Studies and Adverse Reactions sections to reflect three-year safety and efficacy information in rheumatoid arthritis patients
Approval Date: 9/12/2002
Type of submission: Biologics license supplement


Approval Letter (PDF)

Label (PDF)

Patient Label (Instructions) (PDF)