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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  capmatinib
Trade Name:  
Date Designated:  03/15/2019
Orphan Designation:  Treatment of non-small cell lung cancer with MET genomic tumor aberrations
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  05/06/2020 
Approved Labeled Indication:  Tabrecta (capmatinib) is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Exclusivity End Date:    05/06/2027 
Exclusivity Protected Indication* :  For the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Novartis Pharmaceuticals Corp.
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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