Treats HIV-1 infection. NDA 210807, held by Msd Merck Co. Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate.
As of Nov 14, 2026, NDA 210807 (Delstrigo), held by Msd Merck Co, was first approved by FDA on Aug 30, 2018, with 7 approved supplements and 0 published complete response letters.
DELSTRIGO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg: with no prior 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 history of treatment failure and no known substitutions associated with resistance to the individual components of DELSTRIGO.
| Jan 27, 2022 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Oct 10, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2018 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Delstrigo100MG;300MG;300MG · tablet;oral | Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate | RxReference drug |
| Sep 29, 2026 | Supplement 19Labeling · Standard review | Approved | |
| Oct 29, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Jun 12, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Nov 7, 2024 | Supplement 13Labeling · Standard review | Approved | |
| Jan 27, 2022 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Oct 10, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Sep 19, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Aug 30, 2018 | Original applicationNew 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
