FDA — authorised 12 April 2019
- Marketing authorisation holder: JANSSEN BIOTECH
- Status: approved
🇺🇸 Balversa in United States
FDA authorised Balversa on 12 April 2019
Marketing authorisations
FDA — authorised 12 April 2019
- Application: NDA212018
- Marketing authorisation holder: JANSSEN BIOTECH
- Local brand name: BALVERSA
- Indication: TABLET — ORAL
- Status: approved
Balversa 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 Balversa approved in United States?
Yes. FDA authorised it on 12 April 2019; FDA authorised it on 12 April 2019.
Who is the marketing authorisation holder for Balversa in United States?
JANSSEN BIOTECH holds the US marketing authorisation.