FDA — authorised 1 August 2014
- Application: NDA202324
- Marketing authorisation holder: PF PRISM CV
- Indication: Labeling
- Status: approved
🇺🇸 Inlyta in United States
FDA authorised Inlyta on 1 August 2014
Marketing authorisation
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 1 August 2014.
Who is the marketing authorisation holder for Inlyta in United States?
PF PRISM CV holds the US marketing authorisation.