FDA — authorised 14 December 2023
- Application: NDA213871
- Marketing authorisation holder: PFIZER
- Indication: Efficacy
- Status: approved
FDA authorised Cibinqo on 14 December 2023
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 14 December 2023.
PFIZER holds the US marketing authorisation.