Zyvox

As of Nov 14, 2026, NDA 21130 (Zyvox), held by Pfizer, was first approved by FDA on Apr 18, 2000, with 37 approved supplements and 0 published complete response letters.

First approved: Apr 18, 2000
Review: Priority
Supplements approved: 37
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZYVOX is an oxazolidinone-class antibacterial indicated in adults and children for the treatment of the following infections caused by susceptible Gram-positive bacteria: Nosocomial pneumonia; Community-acquired pneumonia; Complicated skin and skin structure infections, including diabetic foot infections, without concomitant osteomyelitis; Uncomplicated skin and skin structure infections; Vancomycin-resistant Enterococcus faecium infections. Limitations of Use:

ZYVOX is not indicated for the treatment of Gram-negative infections.
The safety and efficacy of ZYVOX formulations given for longer than 28 days have not been evaluated in controlled clinical trials.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 38 submissions below


May 12, 2005	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jun 23, 2004	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jul 22, 2003	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 19, 2002	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Apr 18, 2000	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review Pediatric Medical Review

Products

2 strengths and forms


Zyvox400MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · tablet;oral	Linezolid	DiscontinuedReference drug
Zyvox600MG · tablet;oral	Linezolid	DiscontinuedReference drug

All 38 submissions, including labeling and manufacturing supplements


Oct 21, 2026	Supplement 49Labeling · Standard review	Approved	Letter Label
Jun 9, 2026	Supplement 50Labeling · Standard review	Approved	Label Letter
Jun 27, 2024	Supplement 46Labeling · Standard review	Approved	Label Letter
Jul 18, 2023	Supplement 44Labeling · Standard review	Approved	Label Letter
Oct 26, 2021	Supplement 43Labeling · Standard review	Approved	Letter Label
Sep 1, 2021	Supplement 42Labeling · Standard review	Approved	Label Letter
Jul 16, 2021	Supplement 41Labeling · Standard review	Approved	Label Letter
Aug 5, 2020	Supplement 40Labeling · Standard review	Approved	Label Letter
Aug 5, 2020	Supplement 39Labeling · Standard review	Approved	Label Letter
Feb 1, 2018	Supplement 37Labeling · Standard review	Approved	Label Letter
Jul 13, 2017	Supplement 34Labeling · Standard review	Approved	Letter Label
Jun 5, 2015	Supplement 35Labeling · Standard review	Approved	Label Letter
Jul 28, 2014	Supplement 33Manufacturing · Priority review	Approved	None posted
Jan 24, 2014	Supplement 32Labeling · Standard review	Approved	Letter Label
May 3, 2013	Supplement 24Labeling · Standard review	Approved	Label Letter
May 3, 2013	Supplement 23Labeling · Standard review	Approved	Label Letter
Feb 13, 2012	Supplement 28Labeling · Standard review	Approved	Letter Label
Jul 16, 2010	Supplement 22Labeling · Standard review	Approved	Letter Label
Dec 8, 2009	Supplement 20Labeling · Standard review	Approved	Letter Label
Jun 20, 2008	Supplement 17Labeling · Standard review	Approved	Letter
Jun 20, 2008	Supplement 16Labeling · Standard review	Approved	Label Letter
Feb 19, 2008	Supplement 19Manufacturing · Priority review	Approved	None posted
Sep 18, 2007	Supplement 18Manufacturing · Priority review	Approved	None posted
Jun 8, 2007	Supplement 15Manufacturing · Priority review	Approved	None posted
Apr 26, 2007	Supplement 12Labeling · Standard review	Approved	Review Letter Label
Mar 26, 2007	Supplement 13Manufacturing · Priority review	Approved	None posted
Mar 21, 2007	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 2, 2005	Supplement 10Labeling · Standard review	Approved	Letter
May 12, 2005	Supplement 9Efficacy (new indication or use) · Priority review	Approved	Letter Label
May 12, 2005	Supplement 8Labeling · Standard review	Approved	Label Letter
Feb 10, 2005	Supplement 7Labeling · Standard review	Approved	Letter
Jun 23, 2004	Supplement 6Efficacy (new indication or use) · Priority review	Approved	Letter Label
Jan 5, 2004	Supplement 5Labeling · Standard review	Approved	Letter
Jul 22, 2003	Supplement 4Efficacy (new indication or use) · Standard review	Approved	Letter
Dec 19, 2002	Supplement 3Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Dec 19, 2002	Supplement 2Labeling · Standard review	Approved	Letter Label
Feb 6, 2001	Supplement 1Labeling · Standard review	Approved	None posted
Apr 18, 2000	Original applicationNew molecular entity · Priority review	Approved	Letter Label Review Pediatric Medical Review

Identifiers

Application: NDA 21130
Drugs@FDA: Overview at FDA
Company: Pfizer

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