FDA — authorised 16 March 2005
- Marketing authorisation holder: FUJISAWA HLTHCARE
- Status: approved
🇺🇸 Mycamine in United States
FDA authorised Mycamine on 16 March 2005
Marketing authorisations
FDA — authorised 16 March 2005
- Application: NDA021754
- Marketing authorisation holder: FUJISAWA HLTHCARE
- Local brand name: MYCAMINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 March 2005
- Application: NDA021506
- Marketing authorisation holder: ASTELLAS
- Local brand name: MYCAMINE
- Indication: INJECTABLE — INTRAVENOUS
- Status: approved
FDA — authorised 17 May 2019
- Application: ANDA207344
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: approved
FDA — authorised 28 September 2022
- Application: ANDA215381
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 29 May 2024
- Application: ANDA216438
- Marketing authorisation holder: BIOCON PHARMA
- Status: approved
FDA — authorised 3 April 2025
- Application: ANDA219273
- Marketing authorisation holder: QILU PHARM HAINAN
- Status: approved
FDA — authorised 21 January 2026
- Application: ANDA219712
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Status: approved
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 Mycamine approved in United States?
Yes. FDA authorised it on 16 March 2005; FDA authorised it on 16 March 2005; FDA authorised it on 16 March 2005.
Who is the marketing authorisation holder for Mycamine in United States?
FUJISAWA HLTHCARE holds the US marketing authorisation.