FDA — authorised 1 May 2020
- Application: BLA761145
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: DARZALEX FASPRO
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 DARZALEX FASPRO® in United States
FDA authorised DARZALEX FASPRO® on 1 May 2020
Marketing authorisations
FDA
- Status: approved
DARZALEX FASPRO® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is DARZALEX FASPRO® approved in United States?
Yes. FDA authorised it on 1 May 2020; FDA has authorised it.
Who is the marketing authorisation holder for DARZALEX FASPRO® in United States?
JANSSEN BIOTECH holds the US marketing authorisation.