FDA — authorised 25 March 2025
- Application: NDA218230
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: BLUJEPA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Blujepa in United States
FDA authorised Blujepa on 25 March 2025
Marketing authorisations
FDA
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
Blujepa 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 Blujepa approved in United States?
Yes. FDA authorised it on 25 March 2025; FDA has authorised it.
Who is the marketing authorisation holder for Blujepa in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.