FDA — authorised 25 February 2019
- Application: ANDA207420
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Icosapent in United States
FDA authorised Icosapent on 25 February 2019
Marketing authorisations
FDA — authorised 14 June 2019
- Application: ANDA210107
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 10 July 2019
- Application: ANDA211355
- Marketing authorisation holder: SOFGEN PHARMS
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 August 2019
- Application: ANDA206455
- Marketing authorisation holder: CHARTWELL
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 May 2020
- Application: ANDA211979
- Marketing authorisation holder: CSPC-NBP PHARM
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 June 2020
- Application: ANDA210093
- Marketing authorisation holder: PURACAP PHARM LLC
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 August 2020
- Application: ANDA212504
- Marketing authorisation holder: GLW
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 December 2023
- Application: ANDA211345
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: OMEGA-3-ACID ETHYL ESTERS
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Icosapent 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 Icosapent approved in United States?
Yes. FDA authorised it on 25 February 2019; FDA authorised it on 14 June 2019; FDA authorised it on 10 July 2019.
Who is the marketing authorisation holder for Icosapent in United States?
ASCENT PHARMS INC holds the US marketing authorisation.