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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: plerixafor
Trade Name: Mozobil (r)
Date Designated: 07/10/2003
Orphan Designation: For use to improve the yield of progentor cells in the apheresis product for subsequest stem cell transplantation following myelosuppressive or myeloablative chemotherapy
Orphan Designation Status: Designated/Approved
Genzyme Corporation
500 Kendall Street
Cambridge, Massachusetts 02142
United States

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

Marketing approved:

1 Generic Name: plerixafor
Trade Name: Mozobil (r)
Marketing Approval Date: 12/15/2008
Approved Labeled Indication: To enhance mobilization of hematopoietic stem cells to the peripheral blood for collection and subsequent autologous transplantation in patients with lymphoma and multiple myeloma
Exclusivity End Date: 12/15/2015 
Exclusivity Protected Indication* :  

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