FDA — authorised 15 September 2021
- Marketing authorisation holder: TAKEDA PHARMS USA
- Status: approved
🇺🇸 Exkivity in United States
FDA authorised Exkivity on 15 September 2021
Marketing authorisations
FDA — authorised 15 September 2021
- Application: NDA215310
- Marketing authorisation holder: TAKEDA PHARMS USA
- Local brand name: EXKIVITY
- Indication: CAPSULE — ORAL
- Status: approved
Exkivity 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 Exkivity approved in United States?
Yes. FDA authorised it on 15 September 2021; FDA authorised it on 15 September 2021.
Who is the marketing authorisation holder for Exkivity in United States?
TAKEDA PHARMS USA holds the US marketing authorisation.