FDA — authorised 22 December 2021
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Status: approved
🇺🇸 Leqvio in United States
FDA authorised Leqvio on 22 December 2021
Marketing authorisations
FDA — authorised 22 December 2021
- Application: NDA214012
- Marketing authorisation holder: NOVARTIS
- Local brand name: LEQVIO
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Leqvio in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Leqvio approved in United States?
Yes. FDA authorised it on 22 December 2021; FDA authorised it on 22 December 2021.
Who is the marketing authorisation holder for Leqvio in United States?
NOVARTIS PHARMS CORP holds the US marketing authorisation.