FDA — authorised 16 November 2015
- Marketing authorisation holder: JANSSEN BIOTECH
- Status: approved
🇺🇸 Darzalex in United States
FDA authorised Darzalex on 16 November 2015
Marketing authorisations
FDA — authorised 16 November 2015
- Application: BLA761036
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: DARZALEX
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 January 2021
- Application: BLA761145
- Marketing authorisation holder: JANSSEN BIOTECH
- Indication: Efficacy
- Status: approved
Darzalex 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 Darzalex approved in United States?
Yes. FDA authorised it on 16 November 2015; FDA authorised it on 16 November 2015; FDA authorised it on 15 January 2021.
Who is the marketing authorisation holder for Darzalex in United States?
JANSSEN BIOTECH holds the US marketing authorisation.