FDA — authorised 29 June 2015
- Application: ANDA204028
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Pristiq in United States
FDA authorised Pristiq on 29 June 2015
Marketing authorisations
FDA — authorised 29 June 2015
- Application: ANDA204003
- Marketing authorisation holder: ALEMBIC
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 June 2015
- Application: ANDA204095
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 16 February 2016
- Application: ANDA204083
- Marketing authorisation holder: HIKMA
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 July 2016
- Application: ANDA204065
- Marketing authorisation holder: ACTAVIS LABS FL
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 October 2017
- Application: ANDA204020
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 May 2019
- Application: ANDA204805
- Marketing authorisation holder: PLATINUM
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 January 2025
- Application: ANDA211427
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 March 2026
- Application: ANDA220460
- Marketing authorisation holder: YICHANG HUMANWELL
- Local brand name: DESVENLAFAXINE SUCCINATE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Status: approved
Pristiq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Pristiq approved in United States?
Yes. FDA authorised it on 29 June 2015; FDA authorised it on 29 June 2015; FDA authorised it on 29 June 2015.
Who is the marketing authorisation holder for Pristiq in United States?
RUBICON RESEARCH holds the US marketing authorisation.