Search Orphan Drug Designations and Approvals
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Generic Name: | dabrafenib and trametinib | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | dabrafenib and trametinib |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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