FDA — authorised 5 August 1980
- Application: NDA018312
- Marketing authorisation holder: ORGANON USA INC
- Local brand name: CALDEROL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Rayaldee in United States
FDA authorised Rayaldee on 5 August 1980
Marketing authorisations
FDA — authorised 17 June 2016
- Application: NDA208010
- Marketing authorisation holder: EIRGEN
- Local brand name: RAYALDEE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
The FDA approved EIRGEN's New Drug Application (NDA) 208010 for Rayaldee on 19 January 2024. This approval is for the manufacturing (CMC) indication. The marketing authorisation holder is EIRGEN, and the application was reviewed through the standard expedited pathway.
Rayaldee in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Nephrology approved in United States
Frequently asked questions
Is Rayaldee approved in United States?
Yes. FDA authorised it on 5 August 1980; FDA authorised it on 17 June 2016.
Who is the marketing authorisation holder for Rayaldee in United States?
ORGANON USA INC holds the US marketing authorisation.