FDA — authorised 13 February 2015
- Marketing authorisation holder: EISAI INC
- Status: approved
🇺🇸 Lenvima in United States
FDA authorised Lenvima on 13 February 2015
Marketing authorisations
FDA — authorised 23 October 2023
- Application: NDA206947
- Marketing authorisation holder: EISAI INC
- Indication: Efficacy
- Status: approved
FDA
- Application: ANDA213092
- Marketing authorisation holder: SUN PHARM INDS INC
- Local brand name: LENVATINIB
- Indication: CAPSULE — ORAL
- Status: approved
Lenvima 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 Lenvima approved in United States?
Yes. FDA authorised it on 13 February 2015; FDA authorised it on 23 October 2023; FDA has authorised it.
Who is the marketing authorisation holder for Lenvima in United States?
EISAI INC holds the US marketing authorisation.