FDA — authorised 10 July 2009
- Marketing authorisation holder: ELI LILLY AND CO
- Status: approved
🇺🇸 Effient in United States
FDA authorised Effient on 10 July 2009
Marketing authorisations
FDA — authorised 10 July 2009
- Application: NDA022307
- Marketing authorisation holder: COSETTE
- Local brand name: EFFIENT
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2017
- Application: ANDA205927
- Marketing authorisation holder: MYLAN
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA205897
- Marketing authorisation holder: PANACEA
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
The FDA approved Effient, a medication developed by PANACEA, on 17 April 2024. The approval was granted under the standard expedited pathway. The approved indication for Effient is listed as 'Labeling', but the specific indication is not specified in the available data.
FDA — authorised 16 October 2017
- Application: ANDA205790
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA205888
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 February 2018
- Application: ANDA205987
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 June 2018
- Application: ANDA205913
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 January 2019
- Application: ANDA206021
- Marketing authorisation holder: HEC PHARM
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2020
- Application: ANDA205926
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 January 2023
- Application: ANDA205930
- Marketing authorisation holder: LUPIN
- Local brand name: PRASUGREL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 August 2023
- Application: ANDA213315
- Marketing authorisation holder: UNICHEM
- Status: approved
Effient 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 Effient approved in United States?
Yes. FDA authorised it on 10 July 2009; FDA authorised it on 10 July 2009; FDA authorised it on 12 July 2017.
Who is the marketing authorisation holder for Effient in United States?
ELI LILLY AND CO holds the US marketing authorisation.