Overview
A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.
Background
A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.
Indication
For prophylaxis and treatment of bacterial infections.
Associated Conditions
- Bacterial Infections
- Bacterial Urinary Tract Infections
- Bone and Joint Infections
- Gynecological Infection
- Intraabdominal Infections
- Lower respiratory tract infection bacterial
- Neisseria Gonorrhoeae Infection
- Pelvic Inflammatory Disease (PID)
- Postoperative Infections
- Sepsis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/01/27 | Phase 1 | Completed | |||
2010/10/14 | Phase 2 | Completed | |||
2005/09/16 | Not Applicable | Completed | |||
2004/08/27 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teligent Pharma, Inc. | 52565-053 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 20 mL | 2/27/2018 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9671 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 1 1 | 4/12/2019 | |
| Hikma Pharmaceuticals USA Inc. | 0143-9670 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 1 1 | 4/12/2019 | |
| PAI Holdings, LLC dba PAI Pharma | 0121-0976 | INTRAMUSCULAR, INTRAVENOUS | 1 g in 10 mL | 3/28/2024 | |
| Fresenius Kabi USA, LLC | 63323-385 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 10 mL | 7/30/2018 | |
| Fresenius Kabi USA, LLC | 63323-386 | INTRAVENOUS, INTRAMUSCULAR | 2 g in 20 mL | 7/30/2018 | |
| PAI Holdings, LLC dba PAI Pharma | 0121-0977 | INTRAMUSCULAR, INTRAVENOUS | 2 g in 20 mL | 3/28/2024 | |
| Teligent Pharma, Inc. | 52565-052 | INTRAVENOUS, INTRAMUSCULAR | 1 g in 10 mL | 2/27/2018 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||