FDA — authorised 14 January 2022
- Application: NDA213871
- Marketing authorisation holder: PFIZER
- Local brand name: CIBINQO
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Cibinqo in United States
FDA authorised Cibinqo on 14 January 2022
Marketing authorisation
Cibinqo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Immunology approved in United States
Frequently asked questions
Is Cibinqo approved in United States?
Yes. FDA authorised it on 14 January 2022.
Who is the marketing authorisation holder for Cibinqo in United States?
PFIZER holds the US marketing authorisation.