FDA — authorised 19 October 2009
- Application: NDA022465
- Marketing authorisation holder: NOVARTIS
- Local brand name: VOTRIENT
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Votrient on 19 October 2009
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 19 October 2009; FDA has authorised it.
NOVARTIS holds the US marketing authorisation.