FDA — authorised 26 April 2019
- Application: BLA125559
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Indication: Efficacy
- Status: approved
🇺🇸 Praluent in United States
FDA authorised Praluent on 26 April 2019
Marketing authorisation
Praluent 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 Praluent approved in United States?
Yes. FDA authorised it on 26 April 2019.
Who is the marketing authorisation holder for Praluent in United States?
REGENERON PHARMACEUTICALS holds the US marketing authorisation.