FDA — authorised 3 July 2025
- Application: NDA219301
- Marketing authorisation holder: KALVISTA
- Local brand name: EKTERLY
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Ekterly in United States
FDA authorised Ekterly on 3 July 2025
Marketing authorisations
FDA
- Marketing authorisation holder: KALVISTA
- Status: approved
Ekterly in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Ekterly approved in United States?
Yes. FDA authorised it on 3 July 2025; FDA has authorised it.
Who is the marketing authorisation holder for Ekterly in United States?
KALVISTA holds the US marketing authorisation.