FDA — authorised 26 July 2012
- Application: NDA202057
- Marketing authorisation holder: AMARIN PHARMS
- Status: supplemented
🇺🇸 Vascepa in United States
FDA authorised Vascepa on 26 July 2012
Marketing authorisations
FDA — authorised 21 May 2020
- Application: ANDA209457
- Marketing authorisation holder: HIKMA
- Local brand name: ICOSAPENT ETHYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 June 2021
- Application: ANDA209437
- Marketing authorisation holder: APOTEX
- Local brand name: ICOSAPENT ETHYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 September 2023
- Application: ANDA217844
- Marketing authorisation holder: ONESOURCE SPECIALTY
- Local brand name: ICOSAPENT ETHYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 December 2023
- Application: ANDA217919
- Marketing authorisation holder: HUMANWELL PURACAP
- Local brand name: ICOSAPENT ETHYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 November 2024
- Application: ANDA218899
- Marketing authorisation holder: QILU
- Local brand name: ICOSAPENT ETHYL
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- 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 26 July 2012; FDA authorised it on 21 May 2020; FDA authorised it on 30 June 2021.
Who is the marketing authorisation holder for Vascepa in United States?
AMARIN PHARMS holds the US marketing authorisation.