FDA — authorised 4 December 2014
- Application: NDA203137
- Marketing authorisation holder: GE HEALTHCARE
- Indication: Labeling
- Status: approved
FDA authorised Vizamyl on 4 December 2014
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 4 December 2014; FDA has authorised it.
GE HEALTHCARE holds the US marketing authorisation.