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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: nilotinib
Date Designated: 03/20/2007
Orphan Designation: Treatment of gastrointestinal stromal tumors.
Orphan Designation Status: Designated/Withdrawn
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaeuticals Corporation
One Health Plaza
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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