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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: nelarabine
Trade Name: Arranon
Date Designated: 08/10/2004
Orphan Designation: Treatment of acute lymphoblastic leukemia and lymphoblastic lymphoma
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corp.
One Health Plaza
East Hanover, New Jersey 07936
United States

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

Marketing approved:

1 Generic Name: nelarabine
Trade Name: Arranon
Marketing Approval Date: 10/28/2005
Approved Labeled Indication: Treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens
Exclusivity End Date: 10/28/2012 
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.