FDA — authorised 16 June 2021
- Application: NDA212156
- Marketing authorisation holder: PH HEALTH
- Local brand name: MICAFUNGIN
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Echinocandin in United States
FDA authorised Echinocandin on 16 June 2021
Marketing authorisations
FDA — authorised 30 July 2021
- Application: NDA212125
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: MICAFUNGIN
- Indication: POWDER — INTRAVENOUS
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Echinocandin approved in United States?
Yes. FDA authorised it on 16 June 2021; FDA authorised it on 30 July 2021.
Who is the marketing authorisation holder for Echinocandin in United States?
PH HEALTH holds the US marketing authorisation.