FDA — authorised 27 January 2012
- Application: NDA202324
- Marketing authorisation holder: PF PRISM CV
- Local brand name: INLYTA
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Inlyta in United States
FDA authorised Inlyta on 27 January 2012
Marketing authorisations
FDA
- Application: ANDA219705
- Marketing authorisation holder: SANDOZ INC
- Local brand name: AXITINIB
- Indication: TABLET
- Status: approved
Inlyta in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Inlyta approved in United States?
Yes. FDA authorised it on 27 January 2012; FDA has authorised it.
Who is the marketing authorisation holder for Inlyta in United States?
PF PRISM CV holds the US marketing authorisation.