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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: Cometriq
Date Designated: 11/29/2010
Orphan Designation: Treatment of follicular, medullary and anaplastic thyroid carcinoma and metastatic or locally advanced papillary thyroid cancer.
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: Cometriq
Marketing Approval Date: 11/29/2012
Approved Labeled Indication: Treatment of progressive, metastatic medullary thyroid cancer (MTC).
Exclusivity End Date: 11/29/2019 
Exclusivity Protected Indication* :  
2 Generic Name: cabozantinib
Trade Name: Cabometyx
Marketing Approval Date: 09/17/2021
Approved Labeled Indication: Treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible
Exclusivity End Date: 09/17/2028 
Exclusivity Protected Indication* :  Treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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