Search Orphan Drug Designations and Approvals
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Generic Name: | ibalizumab | ||||||||||||||||
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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 | ||||||||||||||||
Sponsor: |
Theratechnologies Inc. 2015 Peel Street 5th Floor Montreal Canada The sponsor address listed is the last reported by the sponsor to OOPD. |
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Marketing approved: |
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1 | Generic Name: | ibalizumab |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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