Treats human immunodeficiency virus type 1 (HIV-1) infection. NDA 210192, held by Viiv Hlthcare. Dolutegravir Sodium; Rilpivirine Hydrochloride.
As of Nov 14, 2026, NDA 210192 (Juluca), held by Viiv Hlthcare, was first approved by FDA on Nov 21, 2017, with 10 approved supplements and 0 published complete response letters.
JULUCA is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to the individual components of JULUCA.
| Jul 9, 2021 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Jul 14, 2020 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2017 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| JulucaEQ 50MG BASE;EQ 25MG BASE · tablet;oral | Dolutegravir Sodium; Rilpivirine Hydrochloride | RxReference drug |
| Oct 28, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Apr 18, 2024 | Supplement 14Labeling · Standard review | Approved | |
| Oct 7, 2022 | Supplement 13Labeling · Standard review | Approved | |
| Jul 9, 2021 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Jul 14, 2020 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Sep 6, 2018 | Supplement 2Labeling · Standard review | Approved | |
| Sep 6, 2018 | Supplement 4Labeling · Standard review | Approved | |
| Jan 17, 2018 | Supplement 1Labeling · Standard review | Approved | |
| Nov 21, 2017 | Original applicationNew combination · 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
