🇺🇸 Edarbi in United States

FDA authorised Edarbi on 20 July 2022

Marketing authorisations

FDA — authorised 20 July 2022

  • Application: ANDA214489
  • Marketing authorisation holder: LUPIN
  • Local brand name: AZILSARTAN MEDOXOMIL
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

Edarbi 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 Edarbi approved in United States?

Yes. FDA authorised it on 20 July 2022; FDA has authorised it.

Who is the marketing authorisation holder for Edarbi in United States?

LUPIN holds the US marketing authorisation.