Daclizumab Product Approval Information - Licensing Action

Proper name: Daclizumab
Tradename: Zenapax
Manufacturer: Hoffman-La Roche Inc, Nutley, NJ, License #0136
Indication for Use: Prophylaxis of acute organ rejection in patients receiving renal transplants, to be used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids
Approval Date: 12/10/97
Type of submission: Biologics license application

Approval Letter (PDF)

Label (PDF)

Reviews (PDF)
    Clinical (43 pages)
    Clinical Pharmacology (22 pages)
    Nonclinical Pharmacology and Toxicology (12 pages)
    Safety (16 pages)
    Chemistry Review (12 pages)

Page Last Updated: 12/18/2015
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