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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
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.
Exelixis, Inc.
1851 Harbor Bay Parkway
Alameda, California 94502
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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