FDA — authorised 27 December 2019
- Application: ANDA209446
- Marketing authorisation holder: SAWAI USA
- Local brand name: MIRABEGRON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 Betanis in United States
FDA authorised Betanis on 27 December 2019
Marketing authorisations
FDA — authorised 2 January 2025
- Application: ANDA209434
- Marketing authorisation holder: APOTEX
- Local brand name: MIRABEGRON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 May 2025
- Application: ANDA217061
- Marketing authorisation holder: SAWAI USA
- Local brand name: MIRABEGRON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 January 2026
- Application: ANDA219323
- Marketing authorisation holder: ALKEM LABS LTD
- Local brand name: MIRABEGRON
- Indication: FOR SUSPENSION, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 1 May 2026
- Application: ANDA219941
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: MIRABEGRON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA
- Application: ANDA209413
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: MIRABEGRON
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
Betanis in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Betanis approved in United States?
Yes. FDA authorised it on 27 December 2019; FDA authorised it on 2 January 2025; FDA authorised it on 6 May 2025.
Who is the marketing authorisation holder for Betanis in United States?
SAWAI USA holds the US marketing authorisation.