FDA — authorised 30 December 2016
- Application: NDA206110
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 CASPOFUNGIN ACETATE in United States
FDA authorised CASPOFUNGIN ACETATE on 30 December 2016 · 913 US adverse-event reports
Marketing authorisations
FDA — authorised 29 September 2017
- Application: ANDA207092
- Marketing authorisation holder: GLAND
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 29 September 2017
- Application: ANDA207650
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 28 June 2018
- Application: ANDA200833
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 2 July 2018
- Application: ANDA205923
- Marketing authorisation holder: XELLIA PHARMS APS
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 12 July 2018
- Application: ANDA209489
- Marketing authorisation holder: CIPLA
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 1 October 2021
- Application: ANDA211263
- Marketing authorisation holder: AREVA PHARMS
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 18 July 2025
- Application: ANDA216506
- Marketing authorisation holder: HANGZHOU ZHONGMEI
- Local brand name: CASPOFUNGIN ACETATE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- 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: 913
Most-reported reactions
- Drug Ineffective — 339 reports (37.13%)
- Off Label Use — 82 reports (8.98%)
- Multiple Organ Dysfunction Syndrome — 71 reports (7.78%)
- Pyrexia — 64 reports (7.01%)
- Death — 63 reports (6.9%)
- Pneumonia — 62 reports (6.79%)
- Product Use In Unapproved Indication — 61 reports (6.68%)
- Febrile Neutropenia — 58 reports (6.35%)
- Sepsis — 57 reports (6.24%)
- Pathogen Resistance — 56 reports (6.13%)
CASPOFUNGIN ACETATE 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 CASPOFUNGIN ACETATE approved in United States?
Yes. FDA authorised it on 30 December 2016; FDA authorised it on 29 September 2017; FDA authorised it on 29 September 2017.
Who is the marketing authorisation holder for CASPOFUNGIN ACETATE in United States?
FRESENIUS KABI USA holds the US marketing authorisation.