🇺🇸 Itovebi in United States

FDA authorised Itovebi on 10 October 2024

Marketing authorisation

FDA — authorised 10 October 2024

  • Application: NDA219249
  • Marketing authorisation holder: GENENTECH INC
  • Local brand name: ITOVEBI
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Itovebi, a new molecular entity, on 10 October 2024. The approval was granted to GENENTECH INC. under the standard expedited pathway. The indication for Itovebi is not specified in the provided information.

Read official source →

Itovebi 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 Itovebi approved in United States?

Yes. FDA authorised it on 10 October 2024.

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

GENENTECH INC holds the US marketing authorisation.