FDA — authorised 21 December 2023
- Application: NDA217388
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: WAINUA
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA authorised Wainua on 21 December 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 21 December 2023; FDA has authorised it.
ASTRAZENECA AB holds the US marketing authorisation.