FDA — authorised 1 July 2011
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Arcapta Neohaler in United States
FDA authorised Arcapta Neohaler on 1 July 2011
Marketing authorisations
FDA — authorised 1 July 2011
- Application: NDA022383
- Marketing authorisation holder: NOVARTIS
- Local brand name: ARCAPTA NEOHALER
- Indication: POWDER — INHALATION
- Status: approved
Arcapta Neohaler 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 Arcapta Neohaler approved in United States?
Yes. FDA authorised it on 1 July 2011; FDA authorised it on 1 July 2011.
Who is the marketing authorisation holder for Arcapta Neohaler in United States?
NOVARTIS holds the US marketing authorisation.