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Etanercept

Product Approval Information - Licensing Action


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), (Text)

Label (PDF), (Text)


Last Updated: 3/17/2001

 

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Updated: September 25, 2003

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