FDA — authorised 21 July 1976
- Application: NDA017697
- Marketing authorisation holder: BRACCO
- Local brand name: KINEVAC
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Kinevac® in United States
FDA authorised Kinevac® on 21 July 1976
Marketing authorisations
FDA — authorised 22 November 2022
- Application: NDA210850
- Marketing authorisation holder: MAIA PHARMS INC
- Local brand name: SINCALIDE
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA
- Status: approved
Kinevac® in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Kinevac® approved in United States?
Yes. FDA authorised it on 21 July 1976; FDA authorised it on 22 November 2022; FDA has authorised it.
Who is the marketing authorisation holder for Kinevac® in United States?
BRACCO holds the US marketing authorisation.