FDA — authorised 7 April 2009
- Marketing authorisation holder: NOVARTIS
- Status: approved
🇺🇸 Coartem in United States
FDA authorised Coartem on 7 April 2009
Marketing authorisations
FDA — authorised 29 April 2013
- Application: NDA022268
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
Coartem in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Rare Disease approved in United States
Frequently asked questions
Is Coartem approved in United States?
Yes. FDA authorised it on 7 April 2009; FDA authorised it on 29 April 2013.
Who is the marketing authorisation holder for Coartem in United States?
NOVARTIS holds the US marketing authorisation.