FDA — authorised 2 August 2019
- Application: NDA211810
- Marketing authorisation holder: DAIICHI SANKYO INC
- Local brand name: TURALIO
- Indication: CAPSULE — ORAL
- Status: approved
FDA authorised TURALIO™ on 2 August 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 2 August 2019; FDA has authorised it.
DAIICHI SANKYO INC holds the US marketing authorisation.