FDA — authorised 30 December 2021
- Application: NDA214133
- Marketing authorisation holder: STRONGBRIDGE
- Local brand name: RECORLEV
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Recorlev in United States
FDA authorised Recorlev on 30 December 2021
Marketing authorisations
FDA
- Marketing authorisation holder: STRONGBRIDGE
- Status: approved
Recorlev 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 Recorlev approved in United States?
Yes. FDA authorised it on 30 December 2021; FDA has authorised it.
Who is the marketing authorisation holder for Recorlev in United States?
STRONGBRIDGE holds the US marketing authorisation.