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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  imatinib
Trade Name:  Gleevec
Date Designated:  10/11/2005
Orphan Designation:  Treatment of Philadelphia-positive acute lymphoblastic leukemia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/19/2006 
Approved Labeled Indication:  Treatment of adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL)
Exclusivity End Date:    10/19/2013 
Exclusivity Protected Indication* :  
Novartis Pharmaceuticals Corporation
One Health Plaza
Mail Code 105/1E870D
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  imatinib
Trade Name:  Gleevec
Date Designated:  10/11/2005
Orphan Designation:  Treatment of Philadelphia-positive acute lymphoblastic leukemia
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  01/25/2013 
Approved Labeled Indication:  Pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
Exclusivity End Date:    01/25/2020 
Exclusivity Protected Indication* :  Treatment of pediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
Novartis Pharmaceuticals Corporation
One Health Plaza
Mail Code 105/1E870D
East Hanover, New Jersey 07936
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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