FDA — authorised 14 July 2000
- Application: NDA021078
- Marketing authorisation holder: GLAXOSMITHKLINE
- Status: supplemented
🇺🇸 Malarone in United States
FDA authorised Malarone on 14 July 2000 · 1,295 US adverse-event reports
Marketing authorisations
FDA — authorised 12 January 2011
- Application: ANDA091211
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 May 2014
- Application: ANDA202362
- Marketing authorisation holder: MYLAN
- Local brand name: ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 27 March 2025 – 27 March 2026
- Total reports: 1,295
Most-reported reactions
- Diarrhoea — 165 reports (12.74%)
- Nausea — 164 reports (12.66%)
- Pyrexia — 148 reports (11.43%)
- Vomiting — 132 reports (10.19%)
- Headache — 130 reports (10.04%)
- Malaria — 123 reports (9.5%)
- Drug Ineffective — 116 reports (8.96%)
- Dizziness — 110 reports (8.49%)
- Fatigue — 107 reports (8.26%)
- Malaise — 100 reports (7.72%)
Other Other 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 12 January 2011; FDA authorised it on 27 May 2014.
Who is the marketing authorisation holder for Malarone in United States?
GLAXOSMITHKLINE holds the US marketing authorisation.