Overview
Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to ristocetin that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear. As of January 29 2018, CutisPharma's Firvanq is the only FDA approved vancomycin oral liquid treatment option available for the the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains [LP1196]. Such an oral liquid formulation is expected to make Clostridium difficile associated diarrhea therapy more accessible in comparison to previously available specialty compounding products [LP1196].
Background
Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to ristocetin that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear. As of January 29 2018, CutisPharma's Firvanq is the only FDA approved vancomycin oral liquid treatment option available for the the treatment of Clostridium difficile associated diarrhea and enterocolitis caused by Staphylococcus aureus, including methicillin-resistant strains [LP1196]. Such an oral liquid formulation is expected to make Clostridium difficile associated diarrhea therapy more accessible in comparison to previously available specialty compounding products [LP1196].
Indication
Administered intravenously, vancomycin is indicated in adult and pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections. Administered orally, vancomycin is indicated in adult and pediatric patients for the treatment of Clostridium difficile-associated diarrhea and for enterocolitis caused by Staphylococcus aureus (including methicillin-resistant strains).
Associated Conditions
- Clostridium Difficile Associated Diarrhea (CDAD)
- Enterocolitis caused by Staphylococcus aureus
- Infection caused by staphylococci
- Severe Staphylococcal infection
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/01 | Phase 4 | Not yet recruiting | |||
2025/02/10 | Phase 2 | Not yet recruiting | |||
2025/01/27 | Phase 4 | Not yet recruiting | |||
2024/12/04 | Phase 2 | Recruiting | |||
2024/11/22 | Not Applicable | Not yet recruiting | Leiden University Medical Center | ||
2024/10/15 | Phase 4 | Recruiting | Todd C. Lee MD MPH FIDSA | ||
2024/09/19 | Phase 1 | Recruiting | |||
2024/09/03 | Phase 1 | Recruiting | |||
2024/08/23 | Phase 4 | Not yet recruiting | |||
2024/08/09 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Fresenius Kabi USA, LLC | 63323-203 | INTRAVENOUS | 750 mg in 15 mL | 8/14/2023 | |
| Fresenius Kabi USA, LLC | 63323-295 | INTRAVENOUS | 5 g in 100 mL | 3/9/2021 | |
| Alvogen Inc. | 47781-729 | ORAL | 125 mg in 1 1 | 4/12/2012 | |
| Fresenius Kabi USA, LLC | 63323-284 | INTRAVENOUS | 1 g in 20 mL | 10/11/2019 | |
| Rebel Distributors Corp | 21695-424 | INTRAVENOUS | 500 mg in 10 mL | 8/18/2010 | |
| Baxter Healthcare Corporation | 0338-0124 | INTRAVITREAL | 1.50 g in 300 mL | 1/25/2024 | |
| Hospira, Inc. | 0409-6509 | INTRAVENOUS | 500 mg in 10 mL | 12/22/2022 | |
| NorthStar Rx LLC | 16714-699 | INTRAVENOUS | 10 g in 1 1 | 3/21/2023 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-859 | ORAL | 250 mg in 1 1 | 12/14/2023 | |
| Hospira, Inc. | 0409-1319 | INTRAVENOUS | 500 mg in 5 mL | 12/22/2022 |
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 |
|---|---|---|---|---|---|
| VANCONEX LYOPHILIZED POWDER FOR INJECTION 1G/VIAL | SIN16013P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 1 g/vial | 9/24/2020 | |
| VANCOMYCIN KABI POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 500 MG | SIN15070P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500mg/vial | 8/22/2016 | |
| DHACOCIN for injection 500mg/vial | Mylan Laboratories Limited - Specialty Formulation Facility, Mylan Laboratories Limited - Sterile Product Division | SIN13745P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 mg | 12/14/2009 |
| VANCOSALA POWDER FOR SOLUTION FOR INJECTION OR INFUSION 500mg PER VIAL | SIN15417P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500mg | 2/7/2018 | |
| DIFFORAL CAPSULES 250MG | SIN16932P | CAPSULE | 250 mg | 1/17/2024 | |
| VANCONEX LYOPHILIZED POWDER FOR INJECTION 500MG/VIAL | SIN16014P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 mg/vial | 9/24/2020 | |
| VANCOMYCIN HCl INJECTION 500 mg/vial | SIN08069P | INJECTION, POWDER, FOR SOLUTION | 500 mg/vial | 3/16/1995 | |
| VANCOVER CAPSULES 250MG | SIN16445P | CAPSULE | 250mg | 3/11/2022 | |
| VANCOMYCIN POWDER FOR SOLUTION FOR INJECTION/INFUSION 500mg | Mylan Laboratories Limited [Specialty Formulation Facility] | SIN14527P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 500 mg/vial | 3/14/2014 |
| VANCOVER CAPSULES 125MG | SIN16444P | CAPSULE | 125mg | 3/11/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Vancomycin Hydrochloride Capsules | 国药准字H20244440 | 化学药品 | 胶囊剂 | 7/9/2024 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20243660 | 化学药品 | 注射剂 | 5/8/2024 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20253781 | 化学药品 | 注射剂 | 4/1/2025 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20033366 | 化学药品 | 注射剂 | 4/26/2020 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20084268 | 化学药品 | 注射剂 | 4/24/2023 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20193378 | 化学药品 | 注射剂 | 12/18/2019 | |
| Vancomycin Hydrochloride for Injection | 国药准字HJ20140174 | 化学药品 | 注射剂 | 7/7/2023 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20244808 | 化学药品 | 注射剂 | 9/3/2024 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20244955 | 化学药品 | 注射剂 | 9/19/2024 | |
| Vancomycin Hydrochloride for Injection | 国药准字H20084269 | 化学药品 | 注射剂 | 4/24/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VANCOMYCIN POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 500MG | N/A | N/A | N/A | 3/31/2025 | |
| VANCOMYCIN KABI POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 500MG | N/A | N/A | N/A | 11/6/2015 |