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Etanercept

Product Approval Information - Licensing Action

Proper name: Etanercept
Tradename: Enbrel
Manufacturer: Immunex Corp, Seattle, WA, License #1132
Indication: Reducing signs and symptoms of active arthritis in patients with psoriatic arthritis
Approval Date: 1/15/2002
Type of submission: Biologics license supplement

Approval Letter (Text)

Label (PDF)

Medical Officer Review - Part 1 (PDF), Part 2 (PDF)

Last Updated: 6/20/2003

 

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Updated: September 25, 2003
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