FDA — authorised 19 August 2019
- Marketing authorisation holder: NABRIVA
- Status: approved
🇺🇸 Xenleta in United States
FDA authorised Xenleta on 19 August 2019
Marketing authorisations
FDA — authorised 19 August 2019
- Application: NDA211673
- Marketing authorisation holder: HONG KONG
- Local brand name: XENLETA
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 19 August 2019
- Application: NDA211672
- Marketing authorisation holder: HONG KONG
- Local brand name: XENLETA
- Indication: TABLET — ORAL
- Status: approved
Xenleta 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 Xenleta approved in United States?
Yes. FDA authorised it on 19 August 2019; FDA authorised it on 19 August 2019; FDA authorised it on 19 August 2019.
Who is the marketing authorisation holder for Xenleta in United States?
NABRIVA holds the US marketing authorisation.