FDA — authorised 30 September 2013
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: approved
🇺🇸 Trintellix in United States
FDA authorised Trintellix on 30 September 2013
Marketing authorisations
FDA — authorised 30 September 2014
- Application: NDA204447
- Marketing authorisation holder: TAKEDA PHARMS USA
- Indication: Manufacturing (CMC)
- Status: approved
Trintellix 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 Trintellix approved in United States?
Yes. FDA authorised it on 30 September 2013; FDA authorised it on 30 September 2014.
Who is the marketing authorisation holder for Trintellix in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.