Selzentry

Treats only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection. NDA 22128, held by Viiv Hlthcare. Maraviroc.

As of Nov 13, 2026, NDA 22128 (Selzentry), held by Viiv Hlthcare, was first approved by FDA on Aug 6, 2007, with 13 approved supplements and 0 published complete response letters.

First approved: Aug 6, 2007
Review: Priority
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

SELZENTRY is indicated in combination with other antiretroviral agents for the treatment of only CCR5‑tropic human immunodeficiency virus type 1 (HIV‑1) infection in adult and pediatric patients weighing at least 2 kg. Limitations of Use

SELZENTRY is not recommended in patients with dual/mixed- or CXCR4-tropic HIV-1.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below


Oct 30, 2020	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Nov 4, 2016	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Label
May 27, 2010	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 20, 2009	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 25, 2008	Supplement 1Efficacy (new indication or use)	Approved	Letter
Aug 6, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Products

4 strengths and forms


Selzentry150MG · tablet;oral	Maraviroc	RxReference drug
Selzentry300MG · tablet;oral	Maraviroc	RxReference drug
Selzentry25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Maraviroc	DiscontinuedReference drug
Selzentry75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Maraviroc	DiscontinuedReference drug

All 14 submissions, including labeling and manufacturing supplements


Oct 30, 2020	Supplement 19Efficacy (new indication or use) · Priority review	Approved	Letter Label Medication Guide
Jul 18, 2018	Supplement 18Labeling · Standard review	Approved	Letter Label Medication Guide
Nov 4, 2016	Supplement 17Efficacy (new indication or use) · Priority review	Approved	Review Label
Apr 21, 2015	Supplement 15Labeling · Standard review	Approved	Label Letter
Apr 14, 2014	Supplement 13Manufacturing · Priority review	Approved	None posted
Mar 27, 2014	Supplement 12Labeling · Standard review	Approved	Label Letter
Feb 14, 2013	Supplement 11Labeling · Standard review	Approved	Label Letter
Feb 1, 2013	Supplement 10Labeling · Standard review	Approved	Label Letter
Aug 10, 2012	Supplement 9Labeling	Approved	Label Letter
Oct 21, 2011	Supplement 7Labeling · Standard review	Approved	Letter Label
May 27, 2010	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 20, 2009	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter Label
Nov 25, 2008	Supplement 1Efficacy (new indication or use)	Approved	Letter
Aug 6, 2007	Original applicationNew molecular entity · Priority review	Approved	Review Letter Label

Identifiers

Application: NDA 22128
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