FDA — authorised 28 August 2018
- Application: NDA208065
- Marketing authorisation holder: ASTRAZENECA
- Indication: Labeling
- Status: approved
🇺🇸 Tagrisso in United States
FDA authorised Tagrisso on 28 August 2018
Marketing authorisation
Tagrisso in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Tagrisso approved in United States?
Yes. FDA authorised it on 28 August 2018.
Who is the marketing authorisation holder for Tagrisso in United States?
ASTRAZENECA holds the US marketing authorisation.