Truvada

Treats HIV-1 infection. NDA 21752, held by Gilead. Emtricitabine; Tenofovir Disoproxil Fumarate.

As of Nov 14, 2026, NDA 21752 (Truvada), held by Gilead, was first approved by FDA on Aug 2, 2004, with 32 approved supplements and 0 published complete response letters.

First approved: Aug 2, 2004
Review: Priority
Supplements approved: 32
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

TRUVADA is a combination of EMTRIVA and VIREAD, both nucleoside analog HIV-1 reverse transcriptase inhibitors. TRUVADA is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 17 kg. TRUVADA is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults at high risk. 1.1 Treatment of HIV-1 Infection

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 33 submissions below


May 15, 2018	Supplement 55Efficacy (new indication or use) · Priority review	Approved	Label Letter
Mar 10, 2016	Supplement 47Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 16, 2012	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Letter Label
May 16, 2008	Supplement 16Efficacy (new indication or use)	Approved	Letter
Mar 8, 2006	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 2, 2004	Original applicationNew combination · Priority review	Approved	Review Letter Label Pediatric Medical Review

Products

4 strengths and forms


Truvada200MG;300MG · tablet;oral	Emtricitabine; Tenofovir Disoproxil Fumarate	RxReference drug
Truvada100MG;150MG · tablet;oral	Emtricitabine; Tenofovir Disoproxil Fumarate	RxReference drug
Truvada133MG;200MG · tablet;oral	Emtricitabine; Tenofovir Disoproxil Fumarate	RxReference drug
Truvada167MG;250MG · tablet;oral	Emtricitabine; Tenofovir Disoproxil Fumarate	RxReference drug

All 33 submissions, including labeling and manufacturing supplements


Apr 29, 2024	Supplement 64Labeling · Standard review	Approved	Letter Label Medication Guide
Oct 11, 2023	Supplement 63Manufacturing	Approved	Letter Label Medication Guide
Jun 23, 2020	Supplement 61Labeling · Standard review	Approved	Label Letter
Jul 1, 2019	Supplement 60REMS	Approved	Review Letter
May 15, 2018	Supplement 55Efficacy (new indication or use) · Priority review	Approved	Label Letter
Dec 8, 2017	Supplement 54REMS	Approved	None posted
Jun 8, 2017	Supplement 52REMS	Approved	Letter
Apr 21, 2017	Supplement 53Labeling · Standard review	Approved	Letter Label
Mar 10, 2016	Supplement 47Efficacy (new indication or use) · Standard review	Approved	Label Letter
Feb 25, 2016	Supplement 50Labeling · Standard review	Approved	Letter Label
Jul 11, 2014	Supplement 45Manufacturing · Priority review	Approved	None posted
Jun 18, 2014	Supplement 44REMS	Approved	Letter
Dec 16, 2013	Supplement 43Labeling	Approved	Letter Label
Nov 27, 2013	Supplement 33Manufacturing · Priority review	Approved	None posted
Nov 8, 2013	Supplement 40Manufacturing · Priority review	Approved	None posted
Oct 23, 2013	Supplement 42Labeling	Approved	Letter Label
Aug 21, 2013	Supplement 38Manufacturing · Priority review	Approved	None posted
Aug 15, 2013	Supplement 37Manufacturing · Priority review	Approved	None posted
Jul 8, 2013	Supplement 39Manufacturing · Priority review	Approved	None posted
Jun 17, 2013	Supplement 36Manufacturing · Priority review	Approved	None posted
Jun 17, 2013	Supplement 35Labeling · Standard review	Approved	Letter Label
Jul 16, 2012	Supplement 31Labeling · Standard review	Approved	Label Letter
Jul 16, 2012	Supplement 30Efficacy (new indication or use) · Priority review	Approved	Review Summary Review Letter Label
Jul 8, 2011	Supplement 27Labeling · Standard review	Approved	Label Letter
Jan 15, 2010	Supplement 21Manufacturing · Priority review	Approved	None posted
Nov 6, 2009	Supplement 19Labeling · Standard review	Approved	Letter Label
Nov 4, 2008	Supplement 17Labeling · Standard review	Approved	Letter Label
May 16, 2008	Supplement 16Efficacy (new indication or use)	Approved	Letter
May 21, 2007	Supplement 11Labeling · Standard review	Approved	Letter Label
Mar 8, 2006	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 5, 2005	Supplement 6Labeling · Standard review	Approved	Letter Label
Mar 25, 2005	Supplement 2Labeling · Standard review	Approved	Review Letter Label
Aug 2, 2004	Original applicationNew combination · Priority review	Approved	Review Letter Label Pediatric Medical Review

Identifiers

Application: NDA 21752
Drugs@FDA: Overview at FDA
Company: Gilead Sciences

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