FDA — authorised 28 June 2012
- Application: NDA202611
- Marketing authorisation holder: APGDI
- Local brand name: MYRBETRIQ
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA authorised Beta-3 Agonists, Adrenergic on 28 June 2012
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 28 June 2012; FDA has authorised it.
APGDI holds the US marketing authorisation.