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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  Tacrolimus
Trade Name:  Prograf
Date Designated:  06/06/2005
Orphan Designation:  Prophylaxis of organ rejection in patients receiving heart transplants.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  03/29/2006 
Approved Labeled Indication:  Prophylaxis of organ rejection in patients receiving allogenic heart transplants.
Exclusivity End Date:    03/29/2013 
Exclusivity Protected Indication* :  
Astellas Pharma US, Inc.
Three Parkway North
Deerfield, Illinois 60015
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.