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].
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/08/06 | Phase 2 | Not yet recruiting | Alberta Hip and Knee Clinic | ||
2021/07/30 | Phase 2 | Completed | |||
2021/07/20 | Early Phase 1 | Terminated | Ari M Grinspan | ||
2021/07/02 | Phase 4 | Recruiting | |||
2021/07/02 | Phase 1 | ENROLLING_BY_INVITATION | |||
2021/06/08 | Phase 4 | UNKNOWN | |||
2021/05/24 | Phase 2 | Completed | Patricia Bloom | ||
2021/05/04 | Phase 4 | Completed | |||
2021/04/23 | Phase 4 | Not yet recruiting | |||
2021/04/01 | Phase 4 | Recruiting | Windsor-Essex Compassionate Care Community |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BluePoint Laboratories | 68001-406 | INTRAVENOUS | 5 g in 1 1 | 9/22/2022 | |
| Eugia US LLC | 55150-203 | INTRAVENOUS | 500 mg in 10 mL | 12/7/2023 | |
| HIKMA PHARMACEUTICALS USA INC. | 0143-9163 | INTRAVENOUS, ORAL | 5.13 g in 1 g | 2/3/2023 | |
| Fresenius Kabi USA, LLC | 63323-314 | INTRAVENOUS | 10 g in 100 mL | 4/26/2021 | |
| Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 23155-858 | ORAL | 125 mg in 1 1 | 12/14/2023 | |
| Fresenius Kabi USA, LLC | 63323-314 | INTRAVENOUS | 10 g in 100 mL | 3/9/2021 | |
| Meitheal Pharmaceuticals Inc. | 71288-023 | INTRAVENOUS | 1 g in 20 mL | 8/11/2022 | |
| Xellia Pharmaceuticals USA LLC | 70594-056 | INTRAVENOUS | 750 mg in 150 mL | 9/16/2020 | |
| Fresenius Kabi, LLC | 63323-284 | INTRAVENOUS | 1 g in 20 mL | 4/11/2019 | |
| Camber Pharmaceuticals, Inc. | 31722-211 | INTRAVENOUS | 1 g in 20 mL | 7/20/2022 |
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