FDA — authorised 10 July 2020
- Application: NDA210951
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Labeling
- Status: approved
🇺🇸 Erleada in United States
FDA authorised Erleada on 10 July 2020
Marketing authorisation
Erleada 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 Erleada approved in United States?
Yes. FDA authorised it on 10 July 2020.
Who is the marketing authorisation holder for Erleada in United States?
JANSSEN BIOTECH holds the US marketing authorisation.