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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
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.

Marketing approved:

1 Generic Name: dabrafenib and trametinib
Trade Name: Mekinist
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.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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