Treats HIV-1 RNA less than or equal. NDA 202022, held by Janssen Prods. Rilpivirine Hydrochloride.
As of Nov 13, 2026, NDA 202022 (Edurant), held by Janssen Prods, was first approved by FDA on May 20, 2011, with 18 approved supplements and 0 published complete response letters.
EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.. Limitations of Use: More EDURANT treated subjects with HIV-1 RNA greater than 100,000 copies/mL at the start of therapy experienced virologic failure (HIV-1 RNA ≥50 copies/mL) compared to EDURANT treated subjects with HIV-1 RNA less than or equal to 100,000 copies/mL. ( 1.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2024 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Mar 15, 2024 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Mar 29, 2022 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Mar 29, 2022 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Jan 31, 2022 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2021 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Feb 1, 2018 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Aug 26, 2015 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Dec 7, 2012 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| May 20, 2011 | Original applicationNew molecular entity · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| EdurantEQ 25MG BASE · tablet;oral | Rilpivirine Hydrochloride | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 15, 2024 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Mar 15, 2024 | Supplement 22Efficacy (new indication or use) · Priority review | Approved | |
| Oct 19, 2022 | Supplement 19Labeling · Standard review | Approved | |
| Mar 29, 2022 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Mar 29, 2022 | Supplement 18Efficacy (new indication or use) · Priority review | Approved | |
| Jan 31, 2022 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2021 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| May 14, 2019 | Supplement 13Labeling · Standard review | Approved | |
| Feb 1, 2018 | Supplement 11Efficacy (new indication or use) · Priority review | Approved | |
| Sep 15, 2017 | Supplement 10Labeling · Standard review | Approved | |
| Aug 26, 2015 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| May 5, 2015 | Supplement 9Labeling | Approved | |
| May 1, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Jul 23, 2013 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Jun 21, 2013 | Supplement 5Labeling · Standard review | Approved | |
| Apr 26, 2013 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Dec 7, 2012 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 10, 2012 | Supplement 3Labeling | Approved | |
| May 20, 2011 | Original applicationNew molecular entity · 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
