Overview
A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms.
Indication
For the treatment of the following infections caused by susceptible gram-negative microorganisms: urinary tract infections, lower respiratory tract infections, septicemia, skin and skin-structure infections, intra-abdominal infections, and gynecologic infections.
Associated Conditions
- Bone and Joint Infections
- Cystic Fibrosis (CF)
- Febrile Neutropenia
- Gynecological Infection
- Intraabdominal Infections
- Lower Respiratory Tract Infection (LRTI)
- Osteomyelitis
- Septic Arthritis
- Septicemia
- Skin Infections
- Urinary Tract Infection
- Uncomplicated Gonorrhea
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2016/04/06 | Phase 2 | Terminated | |||
2015/05/20 | N/A | Completed | |||
2014/10/28 | Phase 3 | Completed | Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | ||
2014/07/28 | Phase 3 | Terminated | |||
2013/11/15 | Phase 3 | Completed | |||
2013/03/15 | Phase 3 | Completed | |||
2012/09/21 | Phase 1 | Completed | |||
2012/08/08 | Phase 4 | Completed | |||
2012/07/17 | Phase 3 | Completed | |||
2011/12/26 | Phase 3 | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| AbbVie Inc. | 0074-3878 | INTRAVENOUS | 127 mg in 1 mL | 2/7/2025 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Aztreonam for Injection | 国药准字H20063927 | 化学药品 | 注射剂 | 9/15/2020 | |
| Aztreonam for Injection | 国药准字H20123046 | 化学药品 | 注射剂 | 9/27/2020 | |
| Aztreonam for Injection | 国药准字H20065044 | 化学药品 | 注射剂 | 10/11/2022 | |
| Aztreonam for Injection | 国药准字H20058580 | 化学药品 | 注射剂 | 6/15/2020 | |
| Aztreonam for Injection | 国药准字H20093761 | 化学药品 | 注射剂 | 10/11/2023 | |
| Aztreonam for Injection | 国药准字H20066634 | 化学药品 | 注射剂 | 1/13/2021 | |
| Aztreonam for Injection | 国药准字H20055839 | 化学药品 | 注射剂 | 6/23/2020 | |
| Aztreonam for Injection | 国药准字H20093848 | 化学药品 | 注射剂 | 7/29/2019 | |
| Aztreonam for Injection | 国药准字H20045460 | 化学药品 | 注射剂 | 8/17/2020 | |
| Aztreonam for Injection | 国药准字H20084214 | 化学药品 | 注射剂 | 4/19/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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