FDA — authorised 16 December 2025
- Application: BLA761458
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Local brand name: EXDENSUR
- Indication: INJECTION
- Status: approved
🇺🇸 Exdensur in United States
FDA authorised Exdensur on 16 December 2025
Marketing authorisations
FDA
- Marketing authorisation holder: GLAXOSMITHKLINE LLC
- Status: approved
Exdensur in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Respiratory approved in United States
Frequently asked questions
Is Exdensur approved in United States?
Yes. FDA authorised it on 16 December 2025; FDA has authorised it.
Who is the marketing authorisation holder for Exdensur in United States?
GLAXOSMITHKLINE LLC holds the US marketing authorisation.