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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
Trade Name: Mekinist
Date Designated: 06/24/2022
Orphan Designation: Treatment of malignant glioma with BRAF V600 mutation
Orphan Designation Status: Designated/Approved
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936-1080
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: trametinib
Trade Name: Mekinist
Marketing Approval Date: 03/16/2023
Approved Labeled Indication: in combination with dabrafenib, for the treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
Exclusivity End Date: 03/16/2030 
Exclusivity Protected Indication* :  treatment of pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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