FDA — authorised 14 July 2000
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: approved
🇺🇸 Malarone in United States
FDA authorised Malarone on 14 July 2000
Marketing authorisations
FDA — authorised 14 July 2000
- Application: NDA021078
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: MALARONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 January 2011
- Application: ANDA091211
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Status: approved
FDA — authorised 27 May 2014
- Application: ANDA202362
- Marketing authorisation holder: MYLAN
- Status: approved
Malarone 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 Malarone approved in United States?
Yes. FDA authorised it on 14 July 2000; FDA authorised it on 14 July 2000; FDA authorised it on 12 January 2011.
Who is the marketing authorisation holder for Malarone in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.