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