FDA — authorised 25 April 2016
- Application: NDA208294
- Marketing authorisation holder: ASTRAZENECA
- Status: supplemented
FDA authorised Bevespi on 25 April 2016
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 25 April 2016; FDA has authorised it.
ASTRAZENECA holds the US marketing authorisation.