FDA — authorised 16 March 2005
- Application: NDA021754
- Marketing authorisation holder: FUJISAWA HLTHCARE
- Local brand name: MYCAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Micafungin (Mycamine) in United States
FDA authorised Micafungin (Mycamine) on 16 March 2005
Marketing authorisations
FDA — authorised 16 March 2005
- Application: NDA021506
- Marketing authorisation holder: ASTELLAS
- Local brand name: MYCAMINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
Micafungin (Mycamine) in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Micafungin (Mycamine) approved in United States?
Yes. FDA authorised it on 16 March 2005; FDA authorised it on 16 March 2005.
Who is the marketing authorisation holder for Micafungin (Mycamine) in United States?
FUJISAWA HLTHCARE holds the US marketing authorisation.