Linezolid

Sold as Zyvox, Linezolid In Sodium Chloride 0.9% In Plastic Container. Every FDA application for this active ingredient: 4 branded and 25 generic.

As of Nov 15, 2026, FDA lists 29 applications for Linezolid (sold as Zyvox, Linezolid In Sodium Chloride 0.9% In Plastic Container), first approved Apr 18, 2000, with 12 new uses approved and 0 published complete response letters.

First approved: Apr 18, 2000
Applications: 29
New uses approved: 12
Complete response letters: 0
Medicare spending, 2025: $19.7M

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Linezolid	Part D	$19.6M	+12%	143,517
Zyvox	Part D	$18K	-76%	36

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

LINEZOLID 100 MG/5 ML SUSP: $2.85 per MLGeneric · +24% in a year
LINEZOLID 600 MG TABLET: $1.47 per unitGeneric · -3% in a year

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

ZyvoxDrugs with a new additional pediatric dosage. · Pfizer Japan Inc. · Nov 21, 2012

Clinical Trials

51 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Oral Antibiotic Pharmacokinetics in Young InfantsLinezolid Pharmacokinetics in Young Infants, Pharmacokinetic Analysis · University of Colorado, Denver	Phase 4	Not yet recruiting	Sep 11, 2026
Study of Combinations of Novel Promising Drugs for Pulmonary TuberculosisTuberculosis, Pulmonary · TASK Applied Science	Phase 2	Not yet recruiting	Aug 19, 2026
Sorfequiline-based Regimens in Adults With Newly Diagnosed Drug-sensitive Pulmonary TBTuberculosis, Pulmonary · Global Alliance for TB Drug Development	Phase 2	Recruiting	Jun 26, 2026
Bactericidal Activity of TBD09 in Combination With Other Drugs in Pulmonary TuberculosisDrug Susceptible Pulmonary Tuberculosis · Gates Medical Research Institute	Phase 2	Recruiting	Apr 13, 2026
The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin ResistanceMycobacterium Abscessus Lung Disease · National Taiwan University Hospital	Phase 4	Recruiting	Apr 7, 2026
Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform TrialMycobacterium Abscessus Pulmonary Disease, Mycobacterium Abscessus Infection · The University of Queensland	Phase 2	Not yet recruiting	Mar 20, 2026
Linezolid Tolerance During the BPaL Regimen With Dosage Personalization Based on Therapeutic Drug Monitoring (TDM) During Multidrug-Resistant Tuberculosis TreatmentLinezolid, Tuberculosis Multi Drug Resistant Active · Marco Schiuma	Phase 4	Recruiting	Mar 17, 2026
Prospective, Randomized, Multicenter Clinical Trial of Bisphosphonates Combined With Vancomycin for the Treatment of Cierny-Mader Type I and III OsteomyelitisOsteomyelitis (Refractory) · Second Affiliated Hospital, Zhejiang University, School of Medicine	Phase 3	Not yet recruiting	Feb 27, 2026

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Apr 18, 2000	ZyvoxNDA 21130 · New molecular entity	Pfizer	37	Discontinued
Apr 18, 2000	ZyvoxNDA 21131 · New dosage form	Pfizer	35	Marketed
Apr 18, 2000	ZyvoxNDA 21132 · New dosage form	Pfizer	35	Marketed
Jun 27, 2012	LinezolidANDA 200222	Teva Pharms	5	Discontinued
May 18, 2015	LinezolidANDA 78061	Teva Pharms USA	7	Discontinued
Jun 3, 2015	LinezolidANDA 200068	Hikma	7	Marketed
Jun 18, 2015	Linezolid In Sodium Chloride 0.9% In Plastic ContainerNDA 206473 · New formulation or manufacturer	Hospira	9	Marketed
Jul 7, 2015	LinezolidANDA 205442	Hospira	2	Discontinued
Jul 16, 2015	LinezolidANDA 200904	Sandoz	7	Marketed
Dec 21, 2015	LinezolidANDA 78845	Rising	5	Marketed
Dec 21, 2015	LinezolidANDA 78987	Glenmark Speclt	9	Marketed
Dec 21, 2015	LinezolidANDA 204239	Hetero Labs Ltd V	3	Marketed
Dec 21, 2015	LinezolidANDA 204536	Amneal Pharms	6	Discontinued
Dec 21, 2015	LinezolidANDA 205233	Alembic	2	Marketed
Dec 21, 2015	LinezolidANDA 205517	Alkem Labs Ltd	6	Marketed
Feb 5, 2016	LinezolidANDA 91210	Gate Pharms	0	Discontinued
Mar 15, 2016	LinezolidANDA 204764	Fresenius Kabi USA	5	Marketed
Aug 4, 2016	LinezolidANDA 206917	Eugia Pharma	6	Marketed
Aug 22, 2016	LinezolidANDA 207526	Novel Labs Inc	4	Marketed
Dec 20, 2016	LinezolidANDA 207354	Nang Kuang Pharm Co	8	Marketed
Feb 22, 2017	LinezolidANDA 206097	Zydus Pharms	4	Marketed
Mar 2, 2017	LinezolidANDA 204696	Sagent Pharms Inc	4	Marketed
Jul 7, 2017	LinezolidANDA 207001	Hq Spclt Pharma	6	Marketed
Dec 6, 2017	LinezolidANDA 205154	Steriscience	8	Marketed
Apr 25, 2019	LinezolidANDA 210702	Chartwell Rx	2	Marketed
Aug 22, 2022	LinezolidANDA 206454	Hikma	2	Marketed
Oct 31, 2022	LinezolidANDA 211813	Hetero Labs	2	Marketed
Oct 10, 2024	LinezolidANDA 210378	Macleods Pharms	0	Marketed
Dec 8, 2025	LinezolidANDA 219558	Caplin	0	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA