Viread

Treats HIV-1 infection. NDA 22577, held by Gilead Sciences Inc. Tenofovir Disoproxil Fumarate.

As of Nov 15, 2026, NDA 22577 (Viread), held by Gilead Sciences Inc, was first approved by FDA on Jan 18, 2012, with 12 approved supplements and 0 published complete response letters.

First approved: Jan 18, 2012
Review: Priority
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VIREAD is a nucleotide analog HIV-1 reverse transcriptase inhibitor and an HBV reverse transcriptase inhibitor and is indicated: in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. for the treatment of chronic hepatitis B in adults and pediatric patients 2 years and older weighing at least 10 kg. 1.1 HIV-1 Infection VIREAD is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients 2 years of age and older weighing at least 10 kg. 1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Dec 11, 2018	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 29, 2015	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jul 24, 2013	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 16, 2012	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 7, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 18, 2012	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
Viread40MG/SCOOPFUL · powder;oral	Tenofovir Disoproxil Fumarate	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Apr 24, 2019	Supplement 14Labeling · Standard review	Approved	Label Letter
Dec 11, 2018	Supplement 13Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 30, 2018	Supplement 12Labeling · Standard review	Approved	Label
Apr 7, 2017	Supplement 11Labeling · Standard review	Approved	Letter Label
Feb 16, 2016	Supplement 9Labeling · Standard review	Approved	Letter Label
Dec 2, 2015	Supplement 8Manufacturing · Priority review	Approved	None posted
May 29, 2015	Supplement 7Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 23, 2013	Supplement 6Labeling	Approved	Label Letter
Jul 24, 2013	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Label Letter
Apr 2, 2013	Supplement 4Labeling · Standard review	Approved	Label Letter
Aug 16, 2012	Supplement 2Efficacy (new indication or use) · Priority review	Approved	Letter Label
Aug 7, 2012	Supplement 1Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 18, 2012	Original applicationNew dosage form · Priority review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22577
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