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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: dabrafenib
Date Designated: 02/08/2016
Orphan Designation: Treatment of malignant glioma with BRAF V600 mutation
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Novartis Pharmaceuticals Corporation
1 Health Plaza
Bldg 337
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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