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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: 11/18/2005
Orphan Designation: Treatment of Philadelphia-positive acute lymphoblastic leukemia
Orphan Designation Status: Designated/Approved
Bristol-Myers Squibb Company
P. O Box 5326
Mailstop C 4065
Princeton, New Jersey 08542
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 Philadelphia chromosome-positive acute lymphoblastic leukemia with resistance or intolerance to prior therapy
Exclusivity End Date: 06/28/2013 
Exclusivity Protected Indication* :  
2 Generic Name: Dasatinib
Trade Name: Sprycel
Marketing Approval Date: 12/21/2018
Approved Labeled Indication: SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.
Exclusivity End Date: 12/21/2025 
Exclusivity Protected Indication* :  SPRYCEL (dasatinib) is indicated for the treatment of pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

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