FDA — authorised 4 June 2018
- Application: BLA761075
- Marketing authorisation holder: MYLAN GMBH
- Local brand name: FULPHILA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 FULPHILA in United States
FDA authorised FULPHILA on 4 June 2018
Marketing authorisations
FDA
- Status: approved
FULPHILA in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Hematology approved in United States
Frequently asked questions
Is FULPHILA approved in United States?
Yes. FDA authorised it on 4 June 2018; FDA has authorised it.
Who is the marketing authorisation holder for FULPHILA in United States?
MYLAN GMBH holds the US marketing authorisation.