FDA — authorised 17 July 2023
- Marketing authorisation holder: ASTRAZENECA AB
- Status: approved
🇺🇸 Beyfortus in United States
FDA authorised Beyfortus on 17 July 2023
Marketing authorisations
FDA — authorised 17 July 2023
- Application: BLA761328
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: BEYFORTUS
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Beyfortus, developed by AstraZeneca AB, for its approved indication. This approval was granted through the standard expedited pathway. The application number for this approval is BLA761328.
Beyfortus in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Beyfortus approved in United States?
Yes. FDA authorised it on 17 July 2023; FDA authorised it on 17 July 2023.
Who is the marketing authorisation holder for Beyfortus in United States?
ASTRAZENECA AB holds the US marketing authorisation.