FDA — authorised 28 June 2012
- Marketing authorisation holder: APGDI
- Status: approved
🇺🇸 Myrbetriq in United States
FDA authorised Myrbetriq on 28 June 2012
Marketing authorisations
FDA — authorised 9 February 2015
- Application: NDA202611
- Marketing authorisation holder: APGDI
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 25 March 2021
- Application: NDA213801
- Marketing authorisation holder: APGDI
- Indication: Type 3 - New Dosage Form
- Status: approved
FDA — authorised 29 September 2022
- Application: ANDA209488
- Marketing authorisation holder: ZYDUS PHARMS
- Status: approved
FDA — authorised 30 June 2025
- Application: ANDA217989
- Marketing authorisation holder: QILU
- Status: approved
FDA — authorised 29 December 2025
- Application: ANDA209485
- Marketing authorisation holder: LUPIN LTD
- Indication: Manufacturing (CMC)
- Status: approved
The FDA approved Myrbetriq, manufactured by LUPIN LTD, on 29 December 2025. The approval was granted under the standard expedited pathway. The indication approved was for the manufacturing (CMC) of the drug.
Myrbetriq in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Urology approved in United States
Frequently asked questions
Is Myrbetriq approved in United States?
Yes. FDA authorised it on 28 June 2012; FDA authorised it on 9 February 2015; FDA authorised it on 25 March 2021.
Who is the marketing authorisation holder for Myrbetriq in United States?
APGDI holds the US marketing authorisation.