FDA — authorised 29 April 2013
- Application: NDA022268
- Marketing authorisation holder: NOVARTIS
- Indication: Labeling
- Status: approved
🇺🇸 Coartem in United States
FDA authorised Coartem on 29 April 2013
Marketing authorisation
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 29 April 2013.
Who is the marketing authorisation holder for Coartem in United States?
NOVARTIS holds the US marketing authorisation.