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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: 10/13/2016
Orphan Designation: Treatment of small cell lung cancer (SCLC)
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
South San Francisco, California 94080
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: 03/18/2019
Approved Labeled Indication: TECENTRIQ®, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
Exclusivity End Date: 03/18/2026 
Exclusivity Protected Indication* :  TECENTRIQ®, in combination with carboplatin and etoposide, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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