Etanercept
Product Approval Information - Licensing Action
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)
Last Updated: 10/23/2002
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Updated: September 25, 2003 |