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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: atezolizumab
Trade Name: Tecentriq
Date Designated: 10/08/2020
Orphan Designation: treatment of soft tissue sarcoma
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080-4990
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: atezolizumab
Trade Name: Tecentriq
Marketing Approval Date: 12/09/2022
Approved Labeled Indication: as a single agent for the treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS)
Exclusivity End Date: 12/09/2029 
Exclusivity Protected Indication* :  treatment of adult and pediatric patients 2 years of age and older with unresectable or metastatic alveolar soft part sarcoma (ASPS)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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