🇺🇸 Ibtrozi in United States

FDA authorised Ibtrozi on 11 June 2025

Marketing authorisations

FDA — authorised 11 June 2025

Application: NDA219713
Marketing authorisation holder: NUVATION
Local brand name: IBTROZI
Indication: CAPSULE — ORAL
Status: approved

The FDA granted marketing authorisation to Ibtrozi, a new molecular entity, on 11 June 2025. This approval was granted to NUVATION under the standard expedited pathway. Ibtrozi is indicated for a specific type 1 condition.

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FDA

Marketing authorisation holder: NUVATION
Status: approved

Ibtrozi 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 Ibtrozi approved in United States?

Yes. FDA authorised it on 11 June 2025; FDA has authorised it.

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

NUVATION holds the US marketing authorisation.