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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: trametinib and dabrafenib
Trade Name: MEKINIST and TAFINLAR
Date Designated: 09/20/2012
Orphan Designation: Treatment of Stage IIb through IV melanoma.
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
Office 337 A13.5B
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: trametinib and dabrafenib
Trade Name: MEKINIST and TAFINLAR
Marketing Approval Date: 01/08/2014
Approved Labeled Indication: MEKINIST (trametinib) in combination with dabrafenib for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. This indication is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for MEKINIST in combination with dabrafenib.
Exclusivity End Date: 01/08/2021 
Exclusivity Protected Indication* :  MEKINIST (trametinib) in combination with dabrafenib for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. This indication is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for MEKINIST in combination with dabrafenib.
2 Generic Name: trametinib and dabrafenib
Trade Name: MEKINIST and TAFINLAR
Marketing Approval Date: 01/08/2014
Approved Labeled Indication: TAFINLAR (dabrafenib) in combination with trametinib for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. This indication is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for TAFINLAR in combination with trametinib.
Exclusivity End Date: 01/08/2021 
Exclusivity Protected Indication* :  TAFINLAR (dabrafenib) in combination with trametinib for treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test. This indication is based on the demonstration of durable response rate. Improvement in disease-related symptoms or overall survival has not been demonstrated for TAFINLAR in combination with trametinib.
3 Generic Name: trametinib and dabrafenib
Trade Name: MEKINIST and TAFINLAR
Marketing Approval Date: 04/30/2018
Approved Labeled Indication: MEKINIST is indicated, in combination with dabrafenib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection
Exclusivity End Date: 04/30/2025 
Exclusivity Protected Indication* :  MEKINIST (trametinib) and TAFINLAR (dabrafenib) indicated in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection
4 Generic Name: trametinib and dabrafenib
Trade Name: MEKINIST and TAFINLAR
Marketing Approval Date: 04/30/2018
Approved Labeled Indication: TAFINLAR is indicated, in combination with trametinib, for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection
Exclusivity End Date: 04/30/2025 
Exclusivity Protected Indication* :  MEKINIST (trametinib) and TAFINLAR (dabrafenib) indicated in combination for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection
*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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