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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: nanatinostat and valganciclovir
Date Designated: 11/24/2021
Orphan Designation: Treatment of Epstein Barr Virus-positive diffuse large B-cell lymphoma, not otherwise specified (EBV+ DLBCL, NOS)
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Viracta Subsidiary, Inc.
2533 S. Coast Hwy 101
Suite 210
Cardiff, California 92007
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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