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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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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
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
Theratechnologies Inc.
2015 Peel Street
5th Floor
Montreal, Quebec

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