FDA — authorised 15 April 2015
- Marketing authorisation holder: AMGEN INC
- Status: approved
🇺🇸 Corlanor in United States
FDA authorised Corlanor on 15 April 2015
Marketing authorisations
FDA — authorised 15 April 2015
- Application: NDA206143
- Marketing authorisation holder: AMGEN INC
- Local brand name: CORLANOR
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 April 2019
- Application: NDA209964
- Marketing authorisation holder: AMGEN INC
- Local brand name: CORLANOR
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 5 October 2022
- Application: ANDA213366
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 29 November 2023
- Application: ANDA213442
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 28 April 2025
- Application: ANDA213483
- Marketing authorisation holder: MSN
- Status: approved
Corlanor in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Corlanor approved in United States?
Yes. FDA authorised it on 15 April 2015; FDA authorised it on 15 April 2015; FDA authorised it on 22 April 2019.
Who is the marketing authorisation holder for Corlanor in United States?
AMGEN INC holds the US marketing authorisation.