Overview
Voriconazole (Vfend, Pfizer) is a triazole antifungal medication used to treat serious fungal infections. It is used to treat invasive fungal infections that are generally seen in patients who are immunocompromised. These include invasive candidiasis, invasive aspergillosis, and emerging fungal infections. The increased affinity of voriconazole for 14-alpha sterol demethylase makes it useful against some fluconazole-resistant organisms. Voriconazole was approved by the FDA under the trade name Vfend on May 24, 2002.
Indication
For the treatment of esophageal candidiasis, cadidemia, invasive pulmonary aspergillosis, and serious fungal infections caused by Scedosporium apiospermum and Fusarium spp.
Associated Conditions
- Aspergillosis of the Central Nervous System
- Aspergillosis of the Liver
- Candidemia
- Candidiasis
- Coccidioidomycosis
- Endocarditis caused by Aspergillus
- Esophageal Candidiasis
- Fungal Infections
- Fungal meningitis caused by Exserohilum Infection
- Fusarium infection
- Histoplasmosis
- Invasive Aspergillosis
- Osteomyelitis caused by Aspergillus
- Penicillium marneffei infection
- Peritonitis caused by Aspergillus
- Scedosporium Infection
- Sinusitis aspergillus
- Aspergillus endophthalmitis
- Refractory Oral Candidiasis
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/11/08 | Phase 2 | Not yet recruiting | |||
2024/07/10 | Phase 1 | Recruiting | |||
2024/04/30 | N/A | Completed | |||
2023/09/21 | N/A | Completed | LI YAN | ||
2023/06/09 | N/A | NO_LONGER_AVAILABLE | |||
2022/12/19 | N/A | Completed | |||
2022/07/14 | Phase 1 | Terminated | |||
2022/05/18 | Phase 4 | Completed | |||
2022/03/07 | Early Phase 1 | UNKNOWN | Second Affiliated Hospital, School of Medicine, Zhejiang University | ||
2022/03/03 | Phase 1 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Institutional Inc. | 51079-165 | ORAL | 200 mg in 1 1 | 12/23/2021 | |
| Mylan Pharmaceuticals Inc. | 0378-1640 | ORAL | 200 mg in 1 1 | 6/15/2023 | |
| Major Pharmaceuticals | 0904-7024 | ORAL | 200 mg in 1 1 | 11/17/2020 | |
| Fosun Pharma USA Inc. | 72266-131 | INTRAVENOUS | 10 mg in 1 mL | 1/17/2023 | |
| Hainan Poly Pharm. Co., Ltd | 14335-220 | ORAL | 40 mg in 1 mL | 1/16/2024 | |
| Lupin Pharmaceuticals,Inc. | 43386-089 | ORAL | 200 mg in 1 1 | 1/31/2024 | |
| Alvogen Inc. | 47781-466 | INTRAVENOUS | 10 mg in 1 mL | 5/5/2021 | |
| Amneal Pharmaceuticals LLC | 65162-913 | ORAL | 40 mg in 1 mL | 12/20/2022 | |
| Viona Pharmaceuticals Inc | 72578-062 | ORAL | 50 mg in 1 1 | 2/14/2024 | |
| Novel Laboratories, Inc. | 40032-038 | ORAL | 40 mg in 1 mL | 12/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 5/16/2013 | ||
Authorised | 5/27/2015 | ||
Authorised | 3/19/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| VORICONAZOLE SANDOZ FILM COATED TABLET 200MG | SIN14859P | TABLET, FILM COATED | 200mg | 10/6/2015 | |
| VFEND FILM-COATED TABLET 50 mg | SIN12378P | TABLET, FILM COATED | 50 mg | 8/5/2003 | |
| Vfend Powder for Oral Suspension 40mg/ml | SIN13033P | POWDER, FOR SUSPENSION | 40mg/ml | 10/28/2004 | |
| VORICA VORICONAZOLE POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL | SIN16417P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg/vial | 1/10/2022 | |
| VORITROP 50 FILM COATED TABLET 50 MG | SIN15848P | TABLET, FILM COATED | 50 mg | 11/1/2019 | |
| VORICONAZOLE – AFT POWDER FOR INJECTION 200MG/VIAL | SIN16906P | INJECTION, POWDER, FOR SOLUTION | 200MG/VIAL | 12/8/2023 | |
| VORICONAZOLE KABI POWDER FOR SOLUTION FOR INFUSION 200MG/VIAL | SIN16509P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 200 mg/vial | 6/9/2022 | |
| VORITROP 200 FILM COATED TABLET 200 MG | SIN15847P | TABLET, FILM COATED | 200 mg | 11/1/2019 | |
| VFEND FILM-COATED TABLET 200 mg | SIN12379P | TABLET, FILM COATED | 200 mg | 8/5/2003 | |
| VFEND FOR INFUSION 200 mg/vial | SIN12380P | INJECTION, POWDER, FOR SOLUTION | 10 mg/ml | 8/5/2003 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Voriconazole for Injection | 国药准字H20243003 | 化学药品 | 注射剂 | 1/5/2024 | |
| Voriconazole for Injection | 国药准字H20253998 | 化学药品 | 注射剂 | 4/22/2025 | |
| Voriconazole for Injection | 国药准字H20233364 | 化学药品 | 注射剂 | 5/25/2023 | |
| Voriconazole for Injection | 国药准字H20233212 | 化学药品 | 注射剂 | 2/21/2023 | |
| Voriconazole for Injection | 国药准字H20233085 | 化学药品 | 注射剂 | 4/3/2023 | |
| Voriconazole for Injection | 国药准字H20244553 | 化学药品 | 注射剂 | 7/30/2024 | |
| Voriconazole for Injection | 国药准字H20233295 | 化学药品 | 注射剂 | 3/21/2023 | |
| Voriconazole for Injection | 国药准字H20233367 | 化学药品 | 注射剂 | 3/24/2023 | |
| Voriconazole for Injection | 国药准字H20243112 | 化学药品 | 注射剂 | 1/30/2024 | |
| Voriconazole for Injection | 国药准字HJ20181102 | 化学药品 | 注射剂 | 10/25/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| VORICONAZOLE NORMON POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 200MG | N/A | N/A | N/A | 1/31/2020 | |
| VORISAM POWDER FOR SOLUTION FOR INFUSION 200MG | N/A | i & c (hong kong) limited | N/A | N/A | 3/19/2020 |
| ZOLCYP POWDER FOR SOLUTION FOR INFUSION 200MG | N/A | N/A | N/A | 9/10/2024 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| VORICONAZOLE AN voriconazole 200 mg film-coated tablets bottle | 238274 | Medicine | A | 7/22/2016 | |
| VFEND voriconazole 50mg tablet blister pack | 82507 | Medicine | A | 9/3/2002 | |
| VORICONAZOLE INTERPHARMA voriconazole 200 mg powder for injection vial | 265660 | Medicine | A | 9/16/2016 | |
| VORICONAZOLE AN voriconazole 200 mg powder for injection vial | 238275 | Medicine | A | 7/22/2016 | |
| VORICONAZOLE GH voriconazole 200 mg film-coated tablets bottle | 238269 | Medicine | A | 7/22/2016 | |
| VORICONAZOLE GPPL voriconazole 200 mg powder for injection vial | 238208 | Medicine | A | 7/22/2016 | |
| VORICONAZOLE GENPAR voriconazole 200 mg film-coated tablets bottle | 238236 | Medicine | A | 7/22/2016 | |
| VORCON voriconazole 50 mg tablet blister pack | 235934 | Medicine | A | 7/27/2016 | |
| GenRx Voriconazole voriconazole 200mg tablet blister pack | 218360 | Medicine | A | 1/27/2016 | |
| VTTACK voriconazole 50mg film coated tablet blister pack | 206983 | Medicine | A | 9/9/2015 |
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