Treats HIV-1 infection. NDA 203100, held by Gilead Sciences Inc. Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate.
As of Nov 14, 2026, NDA 203100 (Stribild), held by Gilead Sciences Inc, was first approved by FDA on Aug 27, 2012, with 24 approved supplements and 0 published complete response letters.
STRIBILD is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older weighing at least 35 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/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 STRIBILD.
| Jan 27, 2017 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Dec 17, 2014 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Aug 28, 2014 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Oct 2, 2013 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Aug 27, 2012 | Original applicationNew molecular entity, new combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Stribild150MG;150MG;200MG;300MG · tablet;oral | Cobicistat; Elvitegravir; Emtricitabine; Tenofovir Disoproxil Fumarate | RxReference drug |
| Sep 9, 2021 | Supplement 36Labeling · Standard review | Approved | |
| Aug 21, 2020 | Supplement 35Labeling · Standard review | Approved | |
| Feb 6, 2019 | Supplement 34Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 33Labeling · Standard review | Approved | |
| Aug 7, 2018 | Supplement 32Labeling · Standard review | Approved | |
| Aug 30, 2017 | Supplement 30Labeling · Standard review | Approved | |
| May 4, 2017 | Supplement 29Labeling · Standard review | Approved | |
| Apr 7, 2017 | Supplement 28Labeling · Standard review | Approved | |
| Jan 27, 2017 | Supplement 25Efficacy (new indication or use) · Priority review | Approved | |
| Sep 15, 2016 | Supplement 24Labeling | Approved | |
| Feb 19, 2016 | Supplement 21Labeling · Standard review | Approved | |
| Aug 10, 2015 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Jul 28, 2015 | Supplement 16Labeling · Standard review | Approved | |
| Jun 8, 2015 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Apr 7, 2015 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Dec 17, 2014 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Aug 28, 2014 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Nov 8, 2013 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Oct 23, 2013 | Supplement 9Labeling | Approved | |
| Oct 16, 2013 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Oct 2, 2013 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jun 19, 2013 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 3, 2013 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2013 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Aug 27, 2012 | 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
