FDA — authorised 22 July 1958
- Status: approved
🇺🇸 Keveyis in United States
FDA authorised Keveyis on 22 July 1958
Marketing authorisations
FDA — authorised 22 July 1958
- Application: NDA011366
- Marketing authorisation holder: XERIS
- Local brand name: KEVEYIS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 February 2024
- Application: ANDA215924
- Marketing authorisation holder: TORRENT
- Indication: Labeling
- Status: approved
The FDA approved Keveyis, a treatment for primary aldosteronism, on February 8, 2024. The approval was granted to TORRENT under the standard expedited pathway. Keveyis is a potassium channel activator that helps to reduce aldosterone levels in patients with primary aldosteronism.
FDA — authorised 18 November 2025
- Application: ANDA218783
- Marketing authorisation holder: RISING
- Local brand name: DICHLORPHENAMIDE
- Indication: TABLET — ORAL
- Status: approved
Keveyis in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is Keveyis approved in United States?
Yes. FDA authorised it on 22 July 1958; FDA authorised it on 22 July 1958; FDA authorised it on 8 February 2024.
Who is the marketing authorisation holder for Keveyis in United States?
Marketing authorisation holder not available in our data.