Treats HIV-1 infection. NDA 207561, held by Gilead Sciences Inc. Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate.
As of Nov 14, 2026, NDA 207561 (Genvoya), held by Gilead Sciences Inc, was first approved by FDA on Nov 5, 2015, with 18 approved supplements and 0 published complete response letters.
GENVOYA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per 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 GENVOYA.
| Jan 7, 2022 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Dec 10, 2018 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Nov 22, 2017 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2017 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Aug 15, 2017 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Feb 15, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 15, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 7, 2016 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 7, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Nov 5, 2015 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Genvoya150MG;150MG;200MG;EQ 10MG BASE · tablet;oral | Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Alafenamide Fumarate | RxReference drug |
| Jan 7, 2022 | Supplement 29Efficacy (new indication or use) · Priority review | Approved | |
| Sep 13, 2021 | Supplement 27Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 25Labeling · Standard review | Approved | |
| Dec 2, 2020 | Supplement 24Labeling · Standard review | Approved | |
| Mar 18, 2019 | Supplement 23Labeling · Standard review | Approved | |
| Dec 10, 2018 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Nov 2, 2018 | Supplement 20Labeling · Standard review | Approved | |
| Aug 1, 2018 | Supplement 17Labeling · Standard review | Approved | |
| Nov 22, 2017 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Sep 25, 2017 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Aug 15, 2017 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Feb 15, 2017 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Feb 15, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 7, 2016 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 15, 2016 | Supplement 7Labeling | Approved | |
| Sep 7, 2016 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 8, 2016 | Supplement 3Labeling · Standard review | Approved | |
| Nov 5, 2015 | Original applicationNew molecular entity, new 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
