FDA — authorised 6 March 2015
- Marketing authorisation holder: ASTELLAS
- Status: approved
🇺🇸 Cresemba in United States
FDA authorised Cresemba on 6 March 2015
Marketing authorisations
FDA — authorised 3 April 2015
- Application: NDA207501
- Marketing authorisation holder: ASTELLAS
- Indication: Labeling
- Status: approved
FDA — authorised 8 December 2023
- Application: NDA207500
- Marketing authorisation holder: ASTELLAS
- Indication: Efficacy
- Status: approved
Cresemba 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 Cresemba approved in United States?
Yes. FDA authorised it on 6 March 2015; FDA authorised it on 3 April 2015; FDA authorised it on 8 December 2023.
Who is the marketing authorisation holder for Cresemba in United States?
ASTELLAS holds the US marketing authorisation.