FDA — authorised 28 June 2019
- Marketing authorisation holder: QED THERAP
- Status: approved
🇺🇸 Truseltiq in United States
FDA authorised Truseltiq on 28 June 2019
Marketing authorisations
FDA — authorised 28 May 2021
- Application: NDA214622
- Marketing authorisation holder: HELSINN HLTHCARE
- Local brand name: TRUSELTIQ
- Indication: CAPSULE — ORAL
- Status: approved
Truseltiq 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 Truseltiq approved in United States?
Yes. FDA authorised it on 28 June 2019; FDA authorised it on 28 May 2021.
Who is the marketing authorisation holder for Truseltiq in United States?
QED THERAP holds the US marketing authorisation.