FDA — authorised 12 December 2025
- Application: NDA219491
- Marketing authorisation holder: ENTASIS THERAP
- Local brand name: NUZOLVENCE
- Indication: FOR SUSPENSION — ORAL
- Status: approved
🇺🇸 ZOLIFLODACIN in United States
FDA authorised ZOLIFLODACIN on 12 December 2025
Marketing authorisations
FDA
- Status: approved
ZOLIFLODACIN 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 ZOLIFLODACIN approved in United States?
Yes. FDA authorised it on 12 December 2025; FDA has authorised it.
Who is the marketing authorisation holder for ZOLIFLODACIN in United States?
ENTASIS THERAP holds the US marketing authorisation.