FDA — authorised 1 July 2009
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
🇺🇸 Multaq in United States
FDA authorised Multaq on 1 July 2009
Marketing authorisations
FDA — authorised 19 December 2011
- Application: NDA022425
- Marketing authorisation holder: SANOFI AVENTIS US
- Indication: Labeling
- Status: approved
FDA
- Application: ANDA210678
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: DRONEDARONE
- Indication: TABLET — ORAL
- Status: approved
Multaq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Multaq approved in United States?
Yes. FDA authorised it on 1 July 2009; FDA authorised it on 19 December 2011; FDA has authorised it.
Who is the marketing authorisation holder for Multaq in United States?
SANOFI AVENTIS US holds the US marketing authorisation.