FDA — authorised 29 May 2013
- Application: NDA203085
- Marketing authorisation holder: BAYER HLTHCARE
- Indication: Labeling
- Status: approved
FDA authorised Stivarga on 29 May 2013
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 29 May 2013.
BAYER HLTHCARE holds the US marketing authorisation.