🇺🇸 Kisqali in United States

Kisqali (LEE011) regulatory status in United States.

Marketing authorisation

FDA

  • Status: approved

Kisqali 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 Kisqali approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Kisqali in United States?

Novartis is the originator. The local marketing authorisation holder may differ — check the official source linked above.