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Etanercept

Product Approval Information - Licensing Action

Proper name: Etanercept
Tradename: Enbrel
Manufacturer: Immunex Corp, Seattle, WA, License #1132
Indication for Use: Polyarticular course juvenile rheumatoid arthritis
Approval Date: 5/27/99
Type of submission: Biologics license supplement

Approval Letter (Text), (PDF)

Reviews:
      Clinical (PDF) - Part 1 , Part 2
      Clinical Pharmacology and Biopharmaceutics (PDF)
      Statistical (PDF)

Last Updated: 3/5/2001

 

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Updated: September 25, 2003
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