FDA — authorised 25 August 2017
- Application: BLA761058
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: CYLTEZO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised CYLTEZO on 25 August 2017
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 25 August 2017.
BOEHRINGER INGELHEIM holds the US marketing authorisation.