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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
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.

Marketing approved:

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.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