FDA — authorised 27 March 2017
- Marketing authorisation holder: TESARO INC
- Status: approved
🇺🇸 Zejula in United States
FDA authorised Zejula on 27 March 2017
Marketing authorisations
FDA — authorised 26 April 2023
- Application: NDA214876
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: ZEJULA
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Zejula, a drug developed by GlaxoSmithKline, for its approved indication on 18 June 2025. The application number for this approval is NDA214876. The approval was granted through the standard expedited pathway.
FDA — authorised 12 December 2025
- Application: NDA216793
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Efficacy
- Status: approved
The FDA approved Zejula, a drug developed by JANSSEN BIOTECH, for its approved indication on 12 December 2025. The application number for this approval is NDA216793. Zejula was approved through the standard expedited pathway.
Zejula 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 Zejula approved in United States?
Yes. FDA authorised it on 27 March 2017; FDA authorised it on 26 April 2023; FDA authorised it on 12 December 2025.
Who is the marketing authorisation holder for Zejula in United States?
TESARO INC holds the US marketing authorisation.