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U.S. Department of Health and Human Services

Drugs

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Alemtuzumab Product Approval Information - Licensing Action 5/7/01

Proper name: Alemtuzumab
Tradename: Campath
Manufacturer: Millennium and ILEX Partners, LP, Cambridge, MA , License #1289
Indication for Use: Treatment of patients with B-cell chronic lymphocytic leukemia who have been treated with alkylating agents and who have failed fludarabine therapy
Approval Date: 5/7/2001
Type of submission: Biologics license application

 

Approval Letter (PDF)

Label (PDF)

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