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)