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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 and trametinib
Trade Name: Tafinlar(r) Capsules a nd Mekinist(r) Tablets
Date Designated: 09/01/2016
Orphan Designation: Treatment of patients with anaplastic thyroid cancer and locally advanced or metastatic papillary thyroid cancer whose tumors harbor a BRAF V600 mutation.
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
1 Health Plaza
Building 337
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 and trametinib
Trade Name: Tafinlar(r) Capsules a nd Mekinist(r) Tablets
Marketing Approval Date: 05/04/2018
Approved Labeled Indication: MEKINIST is indicated, in combination with dabrafenib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
Exclusivity End Date: 05/04/2025 
Exclusivity Protected Indication* :  MEKINIST (trametinib) and TAFINLAR (dabrafenib) in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
2 Generic Name: dabrafenib and trametinib
Trade Name: Tafinlar(r) Capsules a nd Mekinist(r) Tablets
Marketing Approval Date: 05/04/2018
Approved Labeled Indication: TAFINLAR is indicated, in combination with trametinib, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
Exclusivity End Date: 05/04/2025 
Exclusivity Protected Indication* :  MEKINIST (trametinib) and TAFINLAR (dabrafenib) in combination, for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer (ATC) with BRAF V600E mutation and with no satisfactory locoregional treatment options
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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