FDA — authorised 17 April 2020
- Marketing authorisation holder: INCYTE CORP
- Status: approved
🇺🇸 Pemazyre in United States
FDA authorised Pemazyre on 17 April 2020
Marketing authorisations
FDA — authorised 17 April 2020
- Application: NDA213736
- Marketing authorisation holder: INCYTE CORP
- Indication: Type 1 - New Molecular Entity
- Status: approved
Pemazyre 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 Pemazyre approved in United States?
Yes. FDA authorised it on 17 April 2020; FDA authorised it on 17 April 2020.
Who is the marketing authorisation holder for Pemazyre in United States?
INCYTE CORP holds the US marketing authorisation.