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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: 06/05/2024
Orphan Designation: treatment of pancreatic neuroendocrine tumors
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: 03/26/2025
Approved Labeled Indication: treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET)
Exclusivity End Date: 03/26/2032 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 12 years of age and older with previously treated, unresectable, locally advanced or metastatic, well-differentiated pancreatic neuroendocrine tumors (pNET)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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