TheraRadar
Data updated: May 26, 2026

AZACTAM (aztreonam)

Infectious Disease Approved 1986-12-31

AZACTAM is indicated for the treatment of Urinary Tract Infection; Pyelonephritis; Cystitis; Lower Respiratory Tract Infection; Pneumonia; Bronchitis; Septicemia; Skin and Skin-Structure Infection.

Source: FDA Label • Bristol-Myers Squibb
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
39
Years on Market

Details

Status
Prescription
First Approved
1986-12-31
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Bristol-Myers Squibb
Active Ingredient: AZTREONAM

AZACTAM Approval History

1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
84 FDA actions from 1986 to 2021 · 1 indication expansions
Apr 2021 SUPPL
Label · Labeling
FDA Letter Label
Jun 2018 SUPPL
Label · Labeling
FDA Letter Label
Sep 2014 SUPPL Priority
Mfg · Manufacturing (CMC)

What AZACTAM Treats

8 indications

AZACTAM is approved for 8 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Urinary Tract Infection
  • Pyelonephritis
  • Cystitis
  • Lower Respiratory Tract Infection
  • Pneumonia
  • Bronchitis
  • Septicemia
  • Skin and Skin-Structure Infection
Source: FDA Label

AZACTAM Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

DALBAVANCIN HYDROCHLORIDE
Fresenius Kabi
2025 1 indic.
CONTEPO
MEITHEAL
2025 2 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to AZACTAM

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AZTREONAM
AZTREONAM
8 shared
Fresenius Kabi
Shared indications:
Urinary Tract InfectionPyelonephritisCystitis +5 more
CEFUROXIME
CEFUROXIME
5 shared
Hikma
Shared indications:
Lower Respiratory Tract InfectionPneumoniaUrinary Tract Infection +2 more
TAZICEF
CEFTAZIDIME
4 shared
Pfizer
Shared indications:
Lower Respiratory Tract InfectionPneumoniaSkin and Skin-Structure Infection +1 more
View all 20 similar drugs Pro
📋

Clinical Trial Registry

11 trials
Trial Sponsor ID Phase Status Title
NCT03978091 results posted 17-0107 5UM1AI104681-09 Ph 1, Ph 2 completed A Trial to Evaluate the Pharmacokinetics and Safety of AVYCAZ(R) in Combination With Aztreonam
NCT03867734 results posted STUDY00003878-02 Ph 2, Ph 3 completed Aztreonam for Pharyngeal Gonorrhea
NCT02894684 AZTEC-CF 2016AZLIND001 Ph 4 completed Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis
NCT02276482 results posted 1986-012 TR701-122, 2014-004023-40 Ph 3 completed Study of Tedizolid Phosphate in Adolescents With Complicated Skin and Soft Tissue Infection (cSSTI) (MK-1986-012)
NCT01659866 results posted STU00059558 EAM-237 Ph 4 completed Antibiotic Prophylaxis for Transrectal Prostate Biopsy
NCT03376529 SPR741-102 Ph 1 completed Phase 1 Study to Evaluate DDI, PK, Safety, Tolerability of SPR741
NCT01984684 results posted RX-3341-303 Ph 3 completed Delafloxacin vs Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT01811732 results posted RX-3341-302 2012-001767-71 Ph 3 completed Delafloxacin Versus Vancomycin and Aztreonam for the Treatment of Acute Bacterial Skin and Skin Structure Infections
NCT02202135 results posted D3720C00001sub Ph 3 terminated Evaluation of Ceftaroline Fosamil vs Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections.
NCT01499277 results posted D3720C00001 2011-004013-16 Ph 3 completed Evaluation of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam in the Treatment of Patients With Skin Infections
NCT00633152 results posted P903-19 Ph 2 completed Efficacy and Safety of Ceftaroline Versus Linezolid in Subjects With Complicated Skin and Skin Structure Infections
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AZACTAM FDA Label Details

Indications & Usage

FDA Label (PDF)

AZACTAM is indicated for the treatment of Urinary Tract Infection; Pyelonephritis; Cystitis; Lower Respiratory Tract Infection; Pneumonia; Bronchitis; Septicemia; Skin and Skin-Structure Infection.

Track AZACTAM with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: NDA050580 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.