FDA — authorised 27 April 2007
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Arnuity Ellipta in United States
FDA authorised Arnuity Ellipta on 27 April 2007
Marketing authorisations
FDA — authorised 1 September 2011
- Application: NDA022051
- Marketing authorisation holder: HALEON US HOLDINGS
- Indication: Labeling
- Status: approved
FDA — authorised 20 August 2014
- Application: NDA205625
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ARNUITY ELLIPTA
- Indication: POWDER — INHALATION
- Status: approved
FDA — authorised 15 September 2015
- Application: NDA204275
- Marketing authorisation holder: GLAXO GRP LTD
- Indication: Labeling
- Status: approved
FDA — authorised 2 December 2022
- Application: NDA209482
- Marketing authorisation holder: GLAXOSMITHKLINE
- Indication: Labeling
- Status: approved
Arnuity 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 Arnuity Ellipta approved in United States?
Yes. FDA authorised it on 27 April 2007; FDA authorised it on 1 September 2011; FDA authorised it on 20 August 2014.
Who is the marketing authorisation holder for Arnuity Ellipta in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.