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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: dasatinib
Trade Name: Sprycel
Date Designated: 11/28/2005
Orphan Designation: Treatment of chronic myelogenous leukemia
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
3401 Princeton Pike, B-3043C
Lawrence Township, New Jersey 08648
United States

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

Marketing approved:

1 Generic Name: dasatinib
Trade Name: Sprycel
Marketing Approval Date: 06/28/2006
Approved Labeled Indication: Treatment of adults with chronic myeloid leukemia with resistance or intolerance to prior therapy including imatinib
Exclusivity End Date: 06/28/2013 
Exclusivity Protected Indication* :  
2 Generic Name: dasatinib
Trade Name: Sprycel
Marketing Approval Date: 11/09/2017
Approved Labeled Indication: Treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase
Exclusivity End Date: 11/09/2024 
Exclusivity Protected Indication* :  Treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase

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