Lowers the risk of sexually acquired HIV-1 infection. NDA 215499, held by Viiv Hlthcare. Cabotegravir.
As of Nov 13, 2026, NDA 215499 (Apretude), held by Viiv Hlthcare, was first approved by FDA on Dec 20, 2021, with 4 approved supplements and 0 published complete response letters.
APRETUDE is indicated for pre‑exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition. Individuals must have a negative HIV-1 test prior to initiating APRETUDE (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. APRETUDE is an HIV-1 integrase strand transfer inhibitor (INSTI) indicated for PrEP to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are at risk for HIV-1 acquisition.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 20, 2024 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 20, 2021 | Original applicationNew formulation or manufacturer · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Apretude600MG/3ML (200MG/ML) · suspension, extended release;intramuscular | Cabotegravir | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 11, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Sep 20, 2024 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Dec 13, 2023 | Supplement 4Labeling · Standard review | Approved | |
| Feb 27, 2023 | Supplement 2Labeling · Standard review | Approved | |
| Dec 20, 2021 | Original applicationNew formulation or manufacturer · 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
