FDA — authorised 17 August 2017
- Application: NDA208558
- Marketing authorisation holder: ASTRAZENECA
- Local brand name: LYNPARZA
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Olaparib 200-300 mg BID, daily on 17 August 2017
Yes. FDA authorised it on 17 August 2017.
ASTRAZENECA holds the US marketing authorisation.