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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Basiliximab
Trade Name:  Simulect
Date Designated:  12/12/1997
Orphan Designation:  Prophylaxis of solid organ rejection.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/12/1998 
Approved Labeled Indication:  Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.
Exclusivity End Date:    05/12/2005 
Exclusivity Protected Indication* :  
Novartis Pharmaceuticals Corporation
59 Route 10
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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