Treats HIV ‑ 1 infection. NDA 213983, held by Viiv Hlthcare. Dolutegravir Sodium.
As of Nov 13, 2026, NDA 213983 (Tivicay Pd), held by Viiv Hlthcare, was first approved by FDA on Jun 12, 2020, with 6 approved supplements and 0 published complete response letters.
TIVICAY and TIVICAY PD are indicated in combination with other antiretroviral agents for the treatment of HIV ‑ 1 infection in adults (treatment-naïve or -experienced) and in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor [INSTI]-naïve) weighing at least 2 kg.
| Aug 25, 2026 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Jul 9, 2021 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jun 12, 2020 | Original applicationNew dosage form · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Tivicay PdEQ 5MG BASE · tablet, for suspension;oral | Dolutegravir Sodium | RxReference drug |
| Aug 25, 2026 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Oct 28, 2025 | Supplement 6Labeling · Standard review | Approved | |
| Apr 18, 2024 | Supplement 4Labeling · Standard review | Approved | |
| Oct 7, 2022 | Supplement 3Labeling · Standard review | Approved | |
| Jul 9, 2021 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Mar 23, 2021 | Supplement 1Labeling · Standard review | Approved | |
| Jun 12, 2020 | 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
