FDA — authorised 4 February 2004
- Application: NDA021266
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
🇺🇸 VORICONAZOLE in United States
FDA authorised VORICONAZOLE on 4 February 2004 · 13,800 US adverse-event reports
Marketing authorisations
FDA — authorised 10 March 2006
- Application: NDA021267
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
FDA — authorised 22 April 2010
- Application: ANDA090547
- Marketing authorisation holder: MYLAN PHARMS INC
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2010
- Application: NDA021630
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
FDA — authorised 12 December 2011
- Application: ANDA200265
- Marketing authorisation holder: SANDOZ INC
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 April 2012
- Application: ANDA091658
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 May 2012
- Application: ANDA090862
- Marketing authorisation holder: SANDOZ INC
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 28 May 2013
- Application: ANDA202361
- Marketing authorisation holder: RISING
- Local brand name: VORICONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 January 2016
- Application: ANDA206837
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 March 2016
- Application: ANDA206398
- Marketing authorisation holder: ALMAJECT
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 13 April 2016
- Application: ANDA205034
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: VORICONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 24 May 2016
- Application: ANDA206747
- Marketing authorisation holder: CADILA
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 May 2016
- Application: ANDA206762
- Marketing authorisation holder: RISING
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 May 2016
- Application: ANDA206799
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: VORICONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 7 September 2016
- Application: ANDA207049
- Marketing authorisation holder: EPIC PHARMA LLC
- Local brand name: VORICONAZOLE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 March 2017
- Application: NDA208562
- Marketing authorisation holder: HIKMA
- Local brand name: VORICONAZOLE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 July 2018
- Application: ANDA208983
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 30 November 2018
- Application: ANDA211661
- Marketing authorisation holder: SLATE RUN PHARMA
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 31 March 2020
- Application: ANDA211099
- Marketing authorisation holder: GLAND
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 9 May 2022
- Application: ANDA214516
- Marketing authorisation holder: MEITHEAL
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 11 October 2022
- Application: ANDA210849
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 2 February 2023
- Application: ANDA212162
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 9 March 2023
- Application: ANDA211264
- Marketing authorisation holder: UBI
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 3 April 2024
- Application: ANDA218533
- Marketing authorisation holder: ASPIRO
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 8 August 2025
- Application: ANDA211598
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: VORICONAZOLE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 November 2025
- Application: ANDA220043
- Marketing authorisation holder: HAINAN POLY PHARM
- Local brand name: VORICONAZOLE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 5 May 2026
- Application: ANDA220078
- Marketing authorisation holder: ZHEJIANG NOVUS
- Local brand name: VORICONAZOLE
- Indication: POWDER — INTRAVENOUS
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 13,800
Most-reported reactions
- Drug Ineffective — 3,814 reports (27.64%)
- Drug Interaction — 2,033 reports (14.73%)
- Off Label Use — 1,979 reports (14.34%)
- Pyrexia — 1,072 reports (7.77%)
- Pneumonia — 909 reports (6.59%)
- Bronchopulmonary Aspergillosis — 886 reports (6.42%)
- Condition Aggravated — 832 reports (6.03%)
- Aspergillus Infection — 803 reports (5.82%)
- Febrile Neutropenia — 750 reports (5.43%)
- Death — 722 reports (5.23%)
VORICONAZOLE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is VORICONAZOLE approved in United States?
Yes. FDA authorised it on 4 February 2004; FDA authorised it on 10 March 2006; FDA authorised it on 22 April 2010.
Who is the marketing authorisation holder for VORICONAZOLE in United States?
PF PRISM CV holds the US marketing authorisation.