FDA — authorised 16 November 2014
- Application: NDA202379
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Zytiga in United States
FDA authorised Zytiga on 16 November 2014
Marketing authorisations
FDA — authorised 31 October 2018
- Application: ANDA208453
- Marketing authorisation holder: APOTEX
- Status: approved
FDA — authorised 5 April 2021
- Application: ANDA209227
- Marketing authorisation holder: GLENMARK SPECLT
- Indication: Labeling
- Status: approved
FDA — authorised 20 December 2021
- Application: ANDA208416
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
FDA — authorised 12 December 2025
- Application: NDA216793
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Efficacy
- Status: approved
The FDA approved Janssen Biotech's New Drug Application (NDA) 216793 for Zytiga. This approval was granted on 12 December 2025. Zytiga is indicated for its approved efficacy in the United States.
Zytiga 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 Zytiga approved in United States?
Yes. FDA authorised it on 16 November 2014; FDA authorised it on 31 October 2018; FDA authorised it on 5 April 2021.
Who is the marketing authorisation holder for Zytiga in United States?
JANSSEN BIOTECH holds the US marketing authorisation.