Treats HIV-1 infection. NDA 205786, held by Msd Sub Merck. Raltegravir Potassium.
As of Nov 14, 2026, NDA 205786 (Isentress), held by Msd Sub Merck, was first approved by FDA on Dec 20, 2013, with 8 approved supplements and 0 published complete response letters.
Adult Patients: ISENTRESS and ISENTRESS HD are human immunodeficiency virus integrase strand transfer inhibitors (HIV-1 INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients. Pediatric Patients: ISENTRESS is
| Jul 14, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Nov 22, 2017 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 26, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2013 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| IsentressEQ 100MG BASE/PACKET · powder;oral | Raltegravir Potassium | RxReference drug |
| May 18, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Jul 14, 2020 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Mar 5, 2018 | Supplement 7Labeling · Standard review | Approved | |
| Nov 22, 2017 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 26, 2017 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 20, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Feb 18, 2015 | Supplement 2Labeling · Standard review | Approved | |
| Apr 8, 2014 | Supplement 1Labeling · Standard review | Approved | |
| Dec 20, 2013 | Original applicationNew dosage form · 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
