FDA — authorised 21 May 2020
- Application: ANDA209457
- Marketing authorisation holder: HIKMA
- Status: approved
🇺🇸 Vascepa in United States
FDA authorised Vascepa on 21 May 2020
Marketing authorisations
FDA — authorised 11 September 2020
- Application: ANDA209525
- Marketing authorisation holder: TEVA PHARMS USA
- Status: approved
FDA — authorised 8 March 2023
- Application: ANDA209499
- Marketing authorisation holder: DR REDDYS
- Status: approved
FDA — authorised 20 April 2023
- Application: ANDA217656
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Status: approved
FDA — authorised 6 August 2025
- Application: ANDA219156
- Marketing authorisation holder: XIAMEN LP PHARM CO
- Status: approved
Vascepa 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 Vascepa approved in United States?
Yes. FDA authorised it on 21 May 2020; FDA authorised it on 11 September 2020; FDA authorised it on 8 March 2023.
Who is the marketing authorisation holder for Vascepa in United States?
HIKMA holds the US marketing authorisation.