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U.S. Department of Health and Human Services

Drugs

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Etanercept Product Approval Information - Licensing Action 6/6/00

Proper name: Etanercept
Tradename: Enbrel
Manufacturer: Immunex Corp, Seattle, WA, License #1132
Expanded Indication: Reducing the signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis, including those who have not previously failed treatment with DMARD
Approval Date: 6/6/2000
Type of submission: Biologics license supplement

 


Approval Letter (PDF)

Label (PDF)