AZACTAM (aztreonam) · LABS DELBERT
To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
Details
- Status
- Prescription
- First Approved
- 1986-12-31
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AZACTAM Approval History
What AZACTAM Treats
13 indicationsAZACTAM is approved for 13 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Urinary Tract Infections
- Pyelonephritis
- Cystitis
- Lower Respiratory Tract Infections
- Pneumonia
- Bronchitis
- Septicemia
- Skin and Skin-Structure Infections
- Intra-abdominal Infections
- Peritonitis
- Gynecologic Infections
- Endometritis
- Pelvic Cellulitis
AZACTAM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
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 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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)To reduce the development of drug-resistant bacteria and maintain the effectiveness of AZACTAM (aztreonam for injection, USP) and other antibacterial drugs, AZACTAM should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. AZACTAM is indicated for the treatment of the ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.