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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Human Umbilical Cord-derived Mesenchymal Stem Cell Injection
Date Designated: 08/09/2023
Orphan Designation: Treatment of idiopathic pulmonary fibrosis
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Wuhan Optics Valley Vcanbiopharma Co., Ltd.
No. 2 Workshop, Floor 2, Building 14, Block B, Wuhan High-tech Medical Devices Park, No. 818, High-Tech Avenue
East Lake High-Tech Development Zone
Wuhan, Hubei 430206
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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