FDA — authorised 21 May 2021
- Application: BLA761210
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: RYBREVANT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 RYBREVANT in United States
FDA authorised RYBREVANT on 21 May 2021
Marketing authorisations
FDA
- Status: approved
RYBREVANT 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 RYBREVANT approved in United States?
Yes. FDA authorised it on 21 May 2021; FDA has authorised it.
Who is the marketing authorisation holder for RYBREVANT in United States?
JANSSEN BIOTECH holds the US marketing authorisation.