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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
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.

Marketing approved:

1 Generic Name: dabrafenib
Trade Name: TAFINLAR
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.

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