FDA — authorised 20 July 2022
- Application: ANDA214489
- Marketing authorisation holder: LUPIN
- Local brand name: AZILSARTAN MEDOXOMIL
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Edarbi on 20 July 2022
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 20 July 2022; FDA has authorised it.
LUPIN holds the US marketing authorisation.