FDA — authorised 17 October 2023
- Application: NDA216834
- Marketing authorisation holder: UCB INC
- Local brand name: ZILBRYSQ
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA authorised Zilbrysq on 17 October 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 17 October 2023; FDA has authorised it.
UCB INC holds the US marketing authorisation.