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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Cytomegalovirus immune globulin (human)
Trade Name: CytoGam
Date Designated: 08/03/1987
Orphan Designation: Prevention or attenuation of primary cytomegalovirus disease in immunosuppressed recipients of organ transplants.
Orphan Designation Status: Designated/Approved
CSL Behring LLC
1020 First Avenue
P. O. Box 61501
King of Prussia, Pennsylvania 19406
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: Cytomegalovirus immune globulin (human)
Trade Name: CytoGam
Marketing Approval Date: 12/04/1998
Approved Labeled Indication: #1) Attenuation of primary CMV disease associated with kidney transplant recipients who are seronegative for CMV and who receive a kidney from a CMV seropositve donor; #2) Prophylaxis of CMV disease associated transplantation of kidney (all other), lung, liver, pancreas and heart.
Exclusivity End Date: 12/04/2005 
Exclusivity Protected Indication* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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