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Drugs

Etanercept Product Approval Information - Licensing Action 5/27/99

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 (PDF)

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

Page Last Updated: 09/30/2016
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