FDA — authorised 24 September 2018
- Marketing authorisation holder: VERASTEM INC
- Status: approved
🇺🇸 Copiktra in United States
FDA authorised Copiktra on 24 September 2018
Marketing authorisations
FDA — authorised 24 September 2018
- Application: NDA211155
- Marketing authorisation holder: SECURA
- Local brand name: COPIKTRA
- Indication: CAPSULE — ORAL
- Status: approved
Copiktra 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 Copiktra approved in United States?
Yes. FDA authorised it on 24 September 2018; FDA authorised it on 24 September 2018.
Who is the marketing authorisation holder for Copiktra in United States?
VERASTEM INC holds the US marketing authorisation.