FDA — authorised 7 April 2009
- Application: NDA022268
- Marketing authorisation holder: NOVARTIS
- Status: supplemented
🇺🇸 Coartem in United States
FDA authorised Coartem on 7 April 2009
Marketing authorisations
FDA
- Status: approved
Other Other approved in United States
Frequently asked questions
Is Coartem approved in United States?
Yes. FDA authorised it on 7 April 2009; FDA has authorised it.
Who is the marketing authorisation holder for Coartem in United States?
NOVARTIS holds the US marketing authorisation.