FDA — authorised 19 January 2017
- Marketing authorisation holder: SYNERGY PHARMS INC
- Status: approved
🇺🇸 Trulance in United States
FDA authorised Trulance on 19 January 2017
Marketing authorisations
FDA — authorised 19 January 2017
- Application: NDA208745
- Marketing authorisation holder: SALIX
- Local brand name: TRULANCE
- Indication: TABLET — ORAL
- Status: approved
Trulance in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Trulance approved in United States?
Yes. FDA authorised it on 19 January 2017; FDA authorised it on 19 January 2017.
Who is the marketing authorisation holder for Trulance in United States?
SYNERGY PHARMS INC holds the US marketing authorisation.