FDA — authorised 13 November 2015
- Application: NDA208065
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: TAGRISSO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Drug: Osimertinib in United States
FDA authorised Drug: Osimertinib on 13 November 2015
Marketing authorisation
Drug: Osimertinib in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Drug: Osimertinib approved in United States?
Yes. FDA authorised it on 13 November 2015.
Who is the marketing authorisation holder for Drug: Osimertinib in United States?
ASTRAZENECA holds the US marketing authorisation.