🇺🇸 Krazati in United States

FDA authorised Krazati on 21 June 2024

Marketing authorisation

FDA — authorised 21 June 2024

Application: NDA216340
Marketing authorisation holder: BRISTOL
Indication: Efficacy
Status: approved

The FDA approved Krazati, a drug developed by Bristol, for its approved indication on 21 June 2024. The application number for this approval is NDA216340. This approval was granted through the standard expedited pathway.

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Krazati 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 Krazati approved in United States?

Yes. FDA authorised it on 21 June 2024.

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

BRISTOL holds the US marketing authorisation.