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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: clofarabine
Trade Name: Clolar
Date Designated: 02/07/2002
Orphan Designation: Treatment of acute lymphoblastic leukemia
Orphan Designation Status: Designated/Approved
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.

Marketing approved:

1 Generic Name: clofarabine
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* :  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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