Treats multidrug-resistant HIV-1 infection failing their current antiretroviral regimen…. NDA 212950, held by Viiv Hlthcare. Fostemsavir Tromethamine.
As of Nov 13, 2026, NDA 212950 (Rukobia), held by Viiv Hlthcare, was first approved by FDA on Jul 2, 2020, with 2 approved supplements and 0 published complete response letters.
RUKOBIA, 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 due to resistance, intolerance, or safety considerations. RUKOBIA, a human immunodeficiency virus type 1 (HIV-1) gp120-directed attachment inhibitor, in combination with other antiretroviral(s), is indicated for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 24, 2022 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jul 2, 2020 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| RukobiaEQ 600MG BASE · tablet, extended release;oral | Fostemsavir Tromethamine | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Jan 24, 2022 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | None posted |
| Jul 2, 2020 | 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
