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U.S. Department of Health and Human Services

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Basiliximab Product Approval Information - Licensing Action

Proper name: Basiliximab
Tradename: Simulect
Manufacturer: Novartis Pharmaceutical Corp, East Hanover, NJ, License #1244
Indication for Use: Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids
Approval Date: 5/12/98
Type of submission: Biologics license application

 


Approval Letter (PDF)

SBA memo (PDF)

Label (PDF)

Reviews (PDF)
    Chemistry, Manufacturing and Controls (20 pages)
    Clinical Efficacy and Safety (36 pages)
    Clinical Pharmacology (17 pages)
    Product (30 pages)
    Pharmacology (3 pages)
    Statistical (17 pages)