FDA — authorised 16 October 2015
- Application: BLA761025
- Marketing authorisation holder: BOEHRINGER INGELHEIM
- Local brand name: PRAXBIND
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised Praxbind on 16 October 2015
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 16 October 2015; FDA has authorised it.
BOEHRINGER INGELHEIM holds the US marketing authorisation.