FDA — authorised 29 April 2014
- Application: NDA205755
- Marketing authorisation holder: NOVARTIS
- Local brand name: ZYKADIA
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Zykadia in United States
FDA authorised Zykadia on 29 April 2014
Marketing authorisations
FDA — authorised 18 March 2019
- Application: NDA211225
- Marketing authorisation holder: NOVARTIS
- Local brand name: ZYKADIA
- Indication: TABLET — ORAL
- Status: approved
Zykadia 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 Zykadia approved in United States?
Yes. FDA authorised it on 29 April 2014; FDA authorised it on 18 March 2019.
Who is the marketing authorisation holder for Zykadia in United States?
NOVARTIS holds the US marketing authorisation.