Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: obinutuzumab
Trade Name: GAZYVA
Date Designated: 04/15/2015
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
Genentech Inc., a member of the Roche Group
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: obinutuzumab
Trade Name: GAZYVA
Marketing Approval Date: 02/26/2016
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen
Exclusivity End Date: 02/26/2023 
Exclusivity Protected Indication* :  in combination with bendamustine followed by Gazyva monotherapy, indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.
2 Generic Name: obinutuzumab
Trade Name: GAZYVA
Marketing Approval Date: 11/16/2017
Approved Labeled Indication: GAZYVA, in combination with bendamustine followed by GAZYVA monotherapy, is indicated for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen; and in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma
Exclusivity End Date: 11/16/2024 
Exclusivity Protected Indication* :  In combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-