Search Orphan Drug Designations and Approvals
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Generic Name: | Busulfan | ||||||||||||||||
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Trade Name: | Busulfex | ||||||||||||||||
Date Designated: | 07/28/1994 | ||||||||||||||||
Orphan Designation: | As preparative therapy in the treatment of malignancies with bone marrow transplantation. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Otsuka Pharmaceutical Company, Ltd 2-9, Kanda-Tsukasamachi Tokyo Japan The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | Busulfan |
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Trade Name: | Busulfex | |
Marketing Approval Date: | 02/04/1999 | |
Approved Labeled Indication: | For use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation for chronic myelogenous leukemia. | |
Exclusivity End Date: | 02/04/2006 | |
Exclusivity Protected Indication* : | ||
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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