FDA — authorised 9 November 2018
- Marketing authorisation holder: MYLAN IRELAND LTD
- Status: approved
🇺🇸 Yupelri in United States
FDA authorised Yupelri on 9 November 2018
Marketing authorisations
FDA — authorised 21 May 2019
- Application: NDA210598
- Marketing authorisation holder: MYLAN IRELAND LTD
- Indication: Labeling
- Status: approved
Yupelri 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 Yupelri approved in United States?
Yes. FDA authorised it on 9 November 2018; FDA authorised it on 21 May 2019.
Who is the marketing authorisation holder for Yupelri in United States?
MYLAN IRELAND LTD holds the US marketing authorisation.