FDA — authorised 20 August 2014
- Application: NDA205625
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ARNUITY ELLIPTA
- Indication: POWDER — INHALATION
- Status: approved
FDA authorised Arnuity Ellipta on 20 August 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 20 August 2014; FDA has authorised it.
GLAXOSMITHKLINE holds the US marketing authorisation.