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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Gancyclovir
Date Designated: 06/07/1985
Orphan Designation: Treatment of severe human cytomegalovirus infections in specific immunosuppressed patient populations.
Orphan Designation Status: Designated/Designation Withdrawn or Revoked
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Burroughs Wellcome Company
3030 Cornwallis Road
P.O. Box 12700
Research Triangle Park, North Carolina 27709
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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