FDA — authorised 4 February 2022
- Application: BLA761164
- Marketing authorisation holder: RECORDATI RARE DISEASES, INC.
- Local brand name: ENJAYMO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised ENJAYMO on 4 February 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 4 February 2022.
RECORDATI RARE DISEASES, INC. holds the US marketing authorisation.