Treats human immunodeficiency virus type 1 (HIV-1) infection. NDA 210251, held by Gilead Sciences Inc. Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate.
As of Nov 13, 2026, NDA 210251 (Biktarvy), held by Gilead Sciences Inc, was first approved by FDA on Feb 7, 2018, with 15 approved supplements and 0 published complete response letters.
BIKTARVY is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 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 with no known or suspected substitutions associated with resistance to bictegravir or tenofovir.
| Jul 30, 2025 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Apr 24, 2024 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Feb 23, 2024 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Oct 14, 2022 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2021 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Feb 24, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 5, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 18, 2019 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 7, 2018 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| BiktarvyEQ 50MG BASE;200MG;EQ 25MG BASE · tablet;oral | Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | RxReference drug |
| BiktarvyEQ 30MG BASE;120MG;EQ 15MG BASE · tablet;oral | Bictegravir Sodium; Emtricitabine; Tenofovir Alafenamide Fumarate | RxReference drug |
| May 21, 2026 | Supplement 26Manufacturing · Standard review | Approved | |
| Jul 30, 2025 | Supplement 23Efficacy (new indication or use) · Standard review | Approved | |
| Oct 8, 2024 | Supplement 20Manufacturing · Standard review | Approved | |
| Apr 24, 2024 | Supplement 19Efficacy (new indication or use) · Priority review | Approved | |
| Feb 23, 2024 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| May 1, 2023 | Supplement 17Labeling · Standard review | Approved | |
| Oct 14, 2022 | Supplement 15Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2021 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Sep 10, 2021 | Supplement 13Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 10Labeling · Standard review | Approved | |
| Feb 24, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Feb 11, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Feb 5, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Aug 2, 2019 | Supplement 6Labeling · Standard review | Approved | |
| Jun 18, 2019 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 7, 2018 | Original applicationNew molecular entity, new 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
