FDA — authorised 25 October 2024
- Application: NDA213972
- Marketing authorisation holder: ITERUM THERAP
- Local brand name: ORLYNVAH
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 sulopenem etzadroxil and probenecid in United States
FDA authorised sulopenem etzadroxil and probenecid on 25 October 2024
Marketing authorisations
FDA
- Status: approved
sulopenem etzadroxil and probenecid in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is sulopenem etzadroxil and probenecid approved in United States?
Yes. FDA authorised it on 25 October 2024; FDA has authorised it.
Who is the marketing authorisation holder for sulopenem etzadroxil and probenecid in United States?
ITERUM THERAP holds the US marketing authorisation.