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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
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* :  
Exelixis, Inc.
1851 Harbor Bay Parkway
Alameda, California 94502
United States

The sponsor address listed is the last reported by the sponsor to OOPD.
 
Generic Name:  cabozantinib
Trade Name:  Cabometyx
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
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:     
Exclusivity Protected Indication* :  
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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