FDA — authorised 12 March 2021
- Application: NDA214155
- Marketing authorisation holder: MELINTA THERAP
- Local brand name: KIMYRSA
- Indication: POWDER — INTRAVENOUS
- Status: approved
🇺🇸 Kimyrsa in United States
FDA authorised Kimyrsa on 12 March 2021
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Kimyrsa approved in United States?
Yes. FDA authorised it on 12 March 2021; FDA has authorised it.
Who is the marketing authorisation holder for Kimyrsa in United States?
MELINTA THERAP holds the US marketing authorisation.