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