FDA — authorised 12 September 2023
- Application: NDA208558
- Marketing authorisation holder: ASTRAZENECA
- Indication: Labeling
- Status: approved
🇺🇸 Lynparza in United States
FDA authorised Lynparza on 12 September 2023
Marketing authorisation
Lynparza 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 Lynparza approved in United States?
Yes. FDA authorised it on 12 September 2023.
Who is the marketing authorisation holder for Lynparza in United States?
ASTRAZENECA holds the US marketing authorisation.