FDA — authorised 18 December 2013
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Incruse Ellipta in United States
FDA authorised Incruse Ellipta on 18 December 2013
Marketing authorisations
FDA — authorised 30 April 2014
- Application: NDA205382
- Marketing authorisation holder: GLAXO GRP ENGLAND
- Local brand name: INCRUSE ELLIPTA
- Indication: POWDER — INHALATION
- Status: approved
FDA — authorised 2 December 2022
- Application: NDA209482
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Labeling
- Status: approved
FDA — authorised 2 June 2023
- Application: NDA203975
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Labeling
- Status: approved
Incruse Ellipta 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 Incruse Ellipta approved in United States?
Yes. FDA authorised it on 18 December 2013; FDA authorised it on 30 April 2014; FDA authorised it on 2 December 2022.
Who is the marketing authorisation holder for Incruse Ellipta in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.