Search Orphan Drug Designations and Approvals
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Generic Name: | cabozantinib | ||||||||||||||||
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Trade Name: | CABOMETYX | ||||||||||||||||
Date Designated: | 03/02/2017 | ||||||||||||||||
Orphan Designation: | Treatment of hepatocellular carcinoma. | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
Exelixis, Inc. 1851 Harbor Bay Parkway Alameda, California 94502 United States The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | cabozantinib |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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