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: ibalizumab
Trade Name: Trogarzo
Date Designated: 10/20/2014
Orphan Designation: Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy
Orphan Designation Status: Designated/Approved
Theratechnologies Inc.
2015 Peel Street
5th Floor
Montreal
Canada

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

Marketing approved:

1 Generic Name: ibalizumab
Trade Name: Trogarzo
Marketing Approval Date: 03/06/2018
Approved Labeled Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Exclusivity End Date: 03/06/2025 
Exclusivity Protected Indication* :  TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-