Treats HIV-1 infection. NDA 205551, held by Viiv Hlthcare. Abacavir Sulfate; Dolutegravir Sodium; Lamivudine.
As of Nov 14, 2026, NDA 205551 (Triumeq), held by Viiv Hlthcare, was first approved by FDA on Aug 22, 2014, with 20 approved supplements and 0 published complete response letters.
TRIUMEQ and TRIUMEQ PD are indicated for the treatment of HIV-1 infection in adults and in pediatric patients aged at least 3 months and weighing at least 6 kg. Limitations of Use: TRIUMEQ and TRIUMEQ PD alone are not recommended in patients with resistance‑associated integrase substitutions or clinically suspected integrase strand transfer inhibitor (INSTI) resistance because the dose of dolutegravir in TRIUMEQ and TRIUMEQ PD is insufficient in these subpopulations. See full prescribing information for TIVICAY (dolutegravir). TRIUMEQ and
| Jun 15, 2023 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Mar 30, 2022 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Mar 1, 2021 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2017 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Apr 21, 2016 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Aug 22, 2014 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| TriumeqEQ 600MG BASE;EQ 50MG BASE;300MG · tablet;oral | Abacavir Sulfate; Dolutegravir Sodium; Lamivudine | RxReference drug |
| Oct 28, 2025 | Supplement 34Labeling · Standard review | Approved | |
| Apr 18, 2024 | Supplement 32Labeling · Standard review | Approved | |
| Jun 15, 2023 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Oct 7, 2022 | Supplement 29Labeling · Standard review | Approved | |
| Mar 30, 2022 | Supplement 28Efficacy (new indication or use) · Priority review | Approved | |
| Mar 23, 2021 | Supplement 26Labeling · Standard review | Approved | |
| Mar 1, 2021 | Supplement 25Efficacy (new indication or use) · Standard review | Approved | |
| Mar 24, 2020 | Supplement 21Labeling · Standard review | Approved | |
| Oct 24, 2019 | Supplement 22Labeling · Standard review | Approved | |
| May 3, 2019 | Supplement 16Labeling · Standard review | Approved | |
| Sep 6, 2018 | Supplement 15Labeling · Standard review | Approved | |
| Sep 6, 2018 | Supplement 14Labeling · Standard review | Approved | |
| May 11, 2018 | Supplement 13Labeling · Standard review | Approved | |
| Nov 21, 2017 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Mar 27, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Apr 21, 2016 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Apr 1, 2016 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Sep 28, 2015 | Supplement 4Labeling · Standard review | Approved | |
| Aug 5, 2015 | Supplement 2Labeling · Standard review | Approved | |
| Jun 15, 2015 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 22, 2014 | Original applicationNew combination · Standard 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
