FDA — authorised 1 February 2002
- Application: NDA021360
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: SUSTIVA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 lumefantrine-artemether and efavirenz in United States
FDA authorised lumefantrine-artemether and efavirenz on 1 February 2002
Marketing authorisations
FDA — authorised 7 April 2009
- Application: NDA022268
- Marketing authorisation holder: NOVARTIS
- Local brand name: COARTEM
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
lumefantrine-artemether and efavirenz 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 lumefantrine-artemether and efavirenz approved in United States?
Yes. FDA authorised it on 1 February 2002; FDA authorised it on 7 April 2009; FDA has authorised it.
Who is the marketing authorisation holder for lumefantrine-artemether and efavirenz in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.