Treats HIV-1 infection. NDA 212888, held by Viiv Hlthcare. Cabotegravir; Rilpivirine.
As of Nov 14, 2026, NDA 212888 (Cabenuva Kit), held by Viiv Hlthcare, was first approved by FDA on Jan 21, 2021, with 10 approved supplements and 1 published complete response letter.
CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.
| Sep 20, 2024 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Mar 29, 2022 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Mar 29, 2022 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 23, 2022 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 7, 2022 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2021 | Original applicationNew molecular entity, new combination · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Dec 19, 2019 | NDA 212888Product Quality/Facility Inspections, Product Quality | Approved |
| Cabenuva Kit400MG/2ML (200MG/ML);600MG/2ML (300MG/ML) · suspension, extended release;intramuscular | Cabotegravir; Rilpivirine | RxReference drug |
| Cabenuva Kit600MG/3ML (200MG/ML);900MG/3ML (300MG/ML) · suspension, extended release;intramuscular | Cabotegravir; Rilpivirine | RxReference drug |
| Nov 26, 2025 | Supplement 17Labeling · Standard review | Approved | |
| Apr 11, 2025 | Supplement 16Labeling · Standard review | Approved | |
| Sep 20, 2024 | Supplement 15Efficacy (new indication or use) · Priority review | Approved | |
| Dec 13, 2023 | Supplement 11Labeling · Standard review | Approved | |
| Feb 27, 2023 | Supplement 8Labeling · Standard review | Approved | |
| Mar 29, 2022 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Mar 29, 2022 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Mar 23, 2022 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 7, 2022 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 31, 2022 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Jan 21, 2021 | Original applicationNew molecular entity, new 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
