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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:  Mekinist
Date Designated:  10/29/2015
Orphan Designation:  Treatment of patients with BRAF mutation positive non-small cell lung cancer.
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/22/2017 
Approved Labeled Indication:  Mekinist in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
Exclusivity End Date:    06/22/2024 
Exclusivity Protected Indication* :  Mekinist in combination with dabrafenib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test; AND Tafinlar in combination with trametinib, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.
Novartis Pharmaceuticals Corporation
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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