Vaccines, Blood & Biologics
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Marketed Products
Below is a list of marketed cell therapy products and related devices.
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Approved Products
- Allogeneic Hematopoietic Progenitor Cells, Cord Blood
Hemacord, New York Blood Center - Autologous Cellular Immunotherapy
Provenge (Sipuleucel-T), Dendreon Corporation - Autologous Cultured Fibroblasts
Laviv (Azficel-T), Fibrocell Technologies Autologous Cultured Chondrocytes
Carticel, Genzyme BioSurgeryBCG Live (Intravesical)
TheraCys, Sanofi Pasteur Limited Lic#1726HPC, Cord Blood
Clinimmune Labs, University of Colorado Cord Blood BankGINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) - Hematopoietic Progenitor Cell
Ducord, HPC Cord Blood, Duke University School of Medicine
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Contact FDA
(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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