FDA — authorised 18 December 2019
- Application: NDA022247
- Marketing authorisation holder: WYETH PHARMS
- Indication: Labeling
- Status: approved
FDA authorised Duavee on 18 December 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 18 December 2019.
WYETH PHARMS holds the US marketing authorisation.