Treats multidrug resistant HIV-1 infection failing their current antiretroviral regimen. BLA 761065, held by Theratechnologies. Ibalizumab-Uiyk.
As of Nov 14, 2026, BLA 761065 (Trogarzo), held by Theratechnologies, was first approved by FDA on Mar 6, 2018, with 5 approved supplements and 0 published complete response letters.
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.
| Oct 3, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Mar 6, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Trogarzo150MG/ML · injectable;injection | Ibalizumab-Uiyk | Rx |
| Dec 12, 2023 | Supplement 20Labeling · Standard review | Approved | |
| Oct 3, 2022 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Apr 22, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Apr 17, 2020 | Supplement 8Labeling | Approved | |
| May 30, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Mar 6, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
