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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: recombinant adeno-associated virus vector serotype-9 carrying the human ATP7A transgene
Date Designated: 07/30/2024
Orphan Designation: treatment of Menkes disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Lantu Biopharma (Guangzhou) Co., Ltd.
Building A, No. 1211, Juquan Road
Huangpu District
Guangzhou City
China

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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