FDA — authorised 2 March 2020
- Marketing authorisation holder: SANOFI AVENTIS US
- Status: approved
FDA authorised Hu38Sb19 on 2 March 2020
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 March 2020.
SANOFI AVENTIS US holds the US marketing authorisation.