FDA — authorised 4 June 2021
- Application: NDA214460
- Marketing authorisation holder: EMERGENT BIODEFENSE
- Local brand name: TEMBEXA
- Indication: SUSPENSION — ORAL
- Status: approved
🇺🇸 Tembexa in United States
FDA authorised Tembexa on 4 June 2021
Marketing authorisations
FDA — authorised 4 June 2021
- Application: NDA214461
- Marketing authorisation holder: EMERGENT BIODEFENSE
- Local brand name: TEMBEXA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Marketing authorisation holder: EMERGENT BIODEFENSE
- Status: approved
Tembexa 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 Tembexa approved in United States?
Yes. FDA authorised it on 4 June 2021; FDA authorised it on 4 June 2021; FDA has authorised it.
Who is the marketing authorisation holder for Tembexa in United States?
EMERGENT BIODEFENSE holds the US marketing authorisation.