FDA — authorised 2 May 1989
- Application: NDA019591
- Marketing authorisation holder: ROCHE
- Local brand name: LARIAM
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Lariam in United States
FDA authorised Lariam on 2 May 1989
Marketing authorisations
FDA — authorised 20 February 2002
- Application: ANDA076175
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: MEFLOQUINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 December 2003
- Application: ANDA076392
- Marketing authorisation holder: BARR
- Local brand name: MEFLOQUINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 October 2004
- Application: ANDA076523
- Marketing authorisation holder: HIKMA
- Local brand name: MEFLOQUINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 21 April 2010
- Application: ANDA077699
- Marketing authorisation holder: HIKMA INTL PHARMS
- Local brand name: MEFLOQUINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Lariam in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Lariam approved in United States?
Yes. FDA authorised it on 2 May 1989; FDA authorised it on 20 February 2002; FDA authorised it on 29 December 2003.
Who is the marketing authorisation holder for Lariam in United States?
ROCHE holds the US marketing authorisation.