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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: 02/13/2017
Orphan Designation: Treatment of Stage llb, llc, lll and IV melanoma
Orphan Designation Status: Designated/Approved
Genentech, Inc.
1 DNA Way
MS 35-5E
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: 07/30/2020
Approved Labeled Indication: indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
Exclusivity End Date: 07/30/2027 
Exclusivity Protected Indication* :  indicated in combination with cobimetinib and vemurafenib for the treatment of patients with BRAF V600 mutation-positive unresectable or metastatic melanoma
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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