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U.S. Department of Health and Human Services

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Aldesleukin Product Approval Information - Licensing Action

Proper name: Aldesleukin
Tradename: Proleukin
Manufacturer: Chiron Corp, Emeryville, CA, License #1106
Indication for Use: New indication for use in adults with metastatic melanoma and updated response data for metastatic renal cell carcinoma patients, as well as revised package insert information
Approval Date: 1/9/98
Type of submission: Biologics license supplement

 


Approval Letter (PDF)

Reviews (PDF)
    Medical (25 pages)
    Statistical (8 pages)
    Toxicology (18 pages)