Search Orphan Drug Designations and Approvals
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Generic Name: | clofarabine | ||||||||||||||||
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Trade Name: | Clolar | ||||||||||||||||
Date Designated: | 02/07/2002 | ||||||||||||||||
Orphan Designation: | Treatment of acute lymphoblastic leukemia | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Genzyme Corporation 4545 Horizon Hill Blvd. San Antonio, Texas 78229 United States 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: | clofarabine |
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Trade Name: | Clolar | |
Marketing Approval Date: | 12/28/2004 | |
Approved Labeled Indication: | Treatment of pediatric patients 1 to 21 years old with relapsed or refractory acute lymphoblastic leukemia after at least two prior regimens | |
Exclusivity End Date: | 12/28/2011 | |
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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