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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 intravenous (human)
Date Designated: 01/28/1991
Orphan Designation: For use in conjunction with ganciclovir sodium for the treatment of cytomegalovirus pneumonia in bone marrow transplant patients.
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Bayer Corporation
Pharmaceutical Division, Biological Products
400 Morgan Lane
New Haven, Connecticut 06516
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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