FDA — authorised 18 December 2013
- Application: NDA203975
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ANORO ELLIPTA
- Indication: POWDER — INHALATION
- Status: approved
FDA authorised Anoro® Ellipta® on 18 December 2013
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 18 December 2013.
GLAXOSMITHKLINE holds the US marketing authorisation.