FDA — authorised 19 July 2024
- Application: BLA761340
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Local brand name: EPYSQLI
- Indication: INJECTION — SOLUTION
- Status: approved
🇺🇸 EPYSQLI in United States
FDA authorised EPYSQLI on 19 July 2024
Marketing authorisations
FDA
- Status: approved
EPYSQLI in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is EPYSQLI approved in United States?
Yes. FDA authorised it on 19 July 2024; FDA has authorised it.
Who is the marketing authorisation holder for EPYSQLI in United States?
SAMSUNG BIOEPIS CO LTD holds the US marketing authorisation.