FDA — authorised 23 May 2023
- Marketing authorisation holder: ENTASIS THERAP
- Status: approved
🇺🇸 Xacduro (Copackaged) in United States
FDA authorised Xacduro (Copackaged) on 23 May 2023
Marketing authorisations
FDA — authorised 23 May 2023
- Application: NDA216974
- Marketing authorisation holder: ENTASIS THERAP
- Local brand name: XACDURO (COPACKAGED)
- Indication: POWDER — INTRAVENOUS
- Status: approved
Xacduro (Copackaged) 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 Xacduro (Copackaged) approved in United States?
Yes. FDA authorised it on 23 May 2023; FDA authorised it on 23 May 2023.
Who is the marketing authorisation holder for Xacduro (Copackaged) in United States?
ENTASIS THERAP holds the US marketing authorisation.