Tivicay

Treats HIV‑1 infection. NDA 204790, held by Viiv Hlthcare. Dolutegravir Sodium.

As of Nov 13, 2026, NDA 204790 (Tivicay), held by Viiv Hlthcare, was first approved by FDA on Aug 12, 2013, with 23 approved supplements and 0 published complete response letters.

First approved: Aug 12, 2013
Review: Priority
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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) aged at least 4 weeks and weighing at least 3 kg.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below


Aug 25, 2026	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Label Letter
Jul 9, 2021	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 12, 2020	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Letter Label
Nov 21, 2017	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jun 9, 2016	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric CDTL Review Pediatric Clinical Pharmacology Review
Apr 22, 2016	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 30, 2015	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 19, 2014	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 12, 2013	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Letter Label

Products

3 strengths and forms


TivicayEQ 50MG BASE · tablet;oral	Dolutegravir Sodium	RxReference drug
TivicayEQ 10MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Dolutegravir Sodium	DiscontinuedReference drug
TivicayEQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Dolutegravir Sodium	DiscontinuedReference drug

All 24 submissions, including labeling and manufacturing supplements


Aug 25, 2026	Supplement 34Efficacy (new indication or use) · Priority review	Approved	Label Letter
Oct 28, 2025	Supplement 33Labeling · Standard review	Approved	Label Letter
Apr 18, 2024	Supplement 31Labeling · Standard review	Approved	Label Letter
Oct 7, 2022	Supplement 30Labeling · Standard review	Approved	Letter Label
Jul 9, 2021	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 23, 2021	Supplement 29Labeling · Standard review	Approved	Label Letter
Jun 12, 2020	Supplement 25Efficacy (new indication or use) · Priority review	Approved	Letter Label
Mar 24, 2020	Supplement 23Labeling · Standard review	Approved	Label Letter
Oct 24, 2019	Supplement 24Labeling · Standard review	Approved	Label Letter
Sep 6, 2018	Supplement 16Labeling · Standard review	Approved	Letter Label
Sep 6, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label
Nov 21, 2017	Supplement 14Efficacy (new indication or use) · Standard review	Approved	Letter Label
Mar 27, 2017	Supplement 13Labeling · Standard review	Approved	Letter Label
Dec 20, 2016	Supplement 12Manufacturing · Standard review	Approved	None posted
Nov 8, 2016	Supplement 11Manufacturing · Standard review	Approved	None posted
Jun 9, 2016	Supplement 8Efficacy (new indication or use) · Priority review	Approved	Label Letter Pediatric CDTL Review Pediatric Clinical Pharmacology Review
Apr 22, 2016	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 5, 2015	Supplement 6Manufacturing · Priority review	Approved	None posted
Aug 5, 2015	Supplement 5Labeling · Standard review	Approved	Letter Label
Jul 30, 2015	Supplement 4Efficacy (new indication or use) · Standard review	Approved	None posted
Dec 19, 2014	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 29, 2014	Supplement 3Manufacturing · Priority review	Approved	None posted
May 12, 2014	Supplement 1Labeling · Standard review	Approved	Letter Label
Aug 12, 2013	Original applicationNew molecular entity · Priority review	Approved	Summary Review Review Letter Label

Identifiers

Application: NDA 204790
Drugs@FDA: Overview at FDA
Company: ViiV Healthcare

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