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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: an immunoglobulin subclass 1 (IgG1) human monoclonal antibody that targets the Nipah virus fusion protein
Date Designated: 08/18/2026
Orphan Designation: treatment of Nipah virus disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Mapp Biopharmaceutical, Inc.
4921 Directors Place, Suite 100
San Diego, California 92129
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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