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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
Trade Name:  TAFINLAR
Date Designated:  01/12/2011
Orphan Designation:  Treatment BRAF V600 mutation positive Stage IIB through IV melanoma
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/29/2013 
Approved Labeled Indication:  Treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA approved test.
Exclusivity End Date:    05/29/2020 
Exclusivity Protected Indication* :  Treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA approved test.
Novartis Pharmaceuticals Corp.
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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