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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cabozantinib
Trade Name: CABOMETYX
Date Designated: 03/02/2017
Orphan Designation: Treatment of hepatocellular carcinoma.
Orphan Designation Status: Designated/Approved
Exelixis, Inc.
1851 Harbor Bay Parkway
Alameda, California 94502
United States

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

Marketing approved:

1 Generic Name: cabozantinib
Trade Name: CABOMETYX
Marketing Approval Date: 01/14/2019
Approved Labeled Indication: CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
Exclusivity End Date: 01/14/2026 
Exclusivity Protected Indication* :  CABOMETYX is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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