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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Allogeneic bone marrow-derived mesenchymal stromal cells (MSCs)
Date Designated: 12/02/2021
Orphan Designation: Treatment of Hypoplastic Left Heart Syndrome
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Longeveron, Inc.
1951 NW 7th Ave., Suite 520
Miami, Florida 33136
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.