FDA — authorised 1 June 2021
- Application: NDA214900
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: BREXAFEMME
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Brexafemme in United States
FDA authorised Brexafemme on 1 June 2021
Marketing authorisations
FDA
- Status: approved
Brexafemme 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 Brexafemme approved in United States?
Yes. FDA authorised it on 1 June 2021; FDA has authorised it.
Who is the marketing authorisation holder for Brexafemme in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.