FDA — authorised 29 February 2008
- Marketing authorisation holder: WYETH PHARMS INC
- Status: approved
🇺🇸 Pristiq in United States
FDA authorised Pristiq on 29 February 2008
Marketing authorisations
FDA — authorised 29 February 2008
- Application: NDA021992
- Marketing authorisation holder: PF PRISM CV
- Local brand name: PRISTIQ
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 March 2013
- Application: NDA204150
- Marketing authorisation holder: ALEMBIC PHARMS LTD
- Local brand name: DESVENLAFAXINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 10 July 2013
- Application: NDA204683
- Marketing authorisation holder: OSMOTICA PHARM CORP
- Local brand name: KHEDEZLA
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 11 October 2013
- Application: NDA205208
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DESVENLAFAXINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 28 January 2014
- Application: NDA205583
- Marketing authorisation holder: SUN PHARM
- Local brand name: DESVENLAFAXINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 15 July 2016
- Application: ANDA204172
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
FDA — authorised 27 April 2017
- Application: ANDA204003
- Marketing authorisation holder: ALEMBIC
- Indication: Labeling
- Status: approved
FDA — authorised 1 October 2018
- Application: ANDA210014
- Marketing authorisation holder: YICHANG HUMANWELL
- Status: approved
FDA
- Application: ANDA204009
- Marketing authorisation holder: ANCHEN PHARMS
- Local brand name: DESVENLAFAXINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- 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 February 2008; FDA authorised it on 29 February 2008; FDA authorised it on 4 March 2013.
Who is the marketing authorisation holder for Pristiq in United States?
WYETH PHARMS INC holds the US marketing authorisation.