Treats HIV-1 infection. NDA 202123, held by Gilead Sciences Inc. Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate.
As of Nov 13, 2026, NDA 202123 (Complera), held by Gilead Sciences Inc, was first approved by FDA on Aug 10, 2011, with 21 approved supplements and 0 published complete response letters.
COMPLERA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: as initial therapy in those with no antiretroviral treatment history with HIV-1 RNA less than or equal to 100,000 copies/mL at the start of therapy or to replace a stable 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 treatment failure and no known substitutions associated with resistance to the individual components of COMPLERA.
| Oct 31, 2018 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Feb 23, 2016 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2013 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jan 25, 2013 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2011 | Original applicationNew combination · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Complera200MG;EQ 25MG BASE;300MG · tablet;oral | Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate | RxReference drug |
| Nov 27, 2019 | Supplement 31Labeling · Standard review | Approved | |
| Oct 31, 2018 | Supplement 29Efficacy (new indication or use) · Standard review | Approved | |
| Apr 7, 2017 | Supplement 27Labeling · Standard review | Approved | |
| Mar 9, 2016 | Supplement 26Manufacturing · Priority review | Approved | None posted |
| Feb 23, 2016 | Supplement 24Labeling · Standard review | Approved | |
| Feb 23, 2016 | Supplement 21Efficacy (new indication or use) · Standard review | Approved | |
| Feb 9, 2016 | Supplement 23Labeling · Standard review | Approved | |
| Dec 29, 2015 | Supplement 22Manufacturing · Priority review | Approved | None posted |
| May 5, 2015 | Supplement 20Labeling | Approved | |
| Sep 16, 2014 | Supplement 18Labeling · Standard review | Approved | |
| Jul 11, 2014 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Jun 5, 2014 | Supplement 16Labeling · Standard review | Approved | |
| Dec 13, 2013 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Nov 8, 2013 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Oct 23, 2013 | Supplement 15Labeling | Approved | |
| Jun 20, 2013 | Supplement 11Labeling · Standard review | Approved | |
| May 10, 2013 | Supplement 9Manufacturing · Priority review | Approved | None posted |
| Apr 19, 2013 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Mar 26, 2013 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Jan 25, 2013 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2012 | Supplement 6Labeling | Approved | |
| Aug 10, 2011 | 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
