FDA — authorised 14 November 2001
- Application: BLA103950
- Marketing authorisation holder: BIOVITRUM AB
- Local brand name: KINERET
- Indication: VIAL — SUBCUTANEOUS
- Status: approved
FDA authorised Anakinra on 14 November 2001
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 November 2001; FDA has authorised it.
BIOVITRUM AB holds the US marketing authorisation.