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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: replication-competent oncolytic herpes simplex virus (oHSV), engineered by removing the two endogenous copies of infected cell protein 34.5 (ICP34.5) and re-inserting one copy of the ICP34.5 gene under transcriptional control mediated by the promoter-enhancer elements of nestin
Date Designated: 05/21/2024
Orphan Designation: treatment of malignant glioma
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Brigham and Women's Hospital
75 Francis Street
Boston, Massachusetts 02115
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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