FDA — authorised 24 July 2015
- Application: BLA125559
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Local brand name: PRALUENT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Alirocumab SAR236553 in United States
FDA authorised Alirocumab SAR236553 on 24 July 2015
Marketing authorisations
FDA
- Status: approved
Alirocumab SAR236553 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Alirocumab SAR236553 approved in United States?
Yes. FDA authorised it on 24 July 2015; FDA has authorised it.
Who is the marketing authorisation holder for Alirocumab SAR236553 in United States?
REGENERON PHARMACEUTICALS holds the US marketing authorisation.