🇺🇸 Revuforj in United States

FDA authorised Revuforj on 15 November 2024

Marketing authorisations

FDA — authorised 15 November 2024

  • Application: NDA218944
  • Marketing authorisation holder: SYNDAX
  • Local brand name: REVUFORJ
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Revuforj, developed by SYNDAX, for its approved indication on 24 October 2025. The application number for this approval is NDA218944. Revuforj was granted marketing authorisation through the standard expedited pathway.

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FDA

  • Marketing authorisation holder: SYNDAX
  • Status: approved

Revuforj 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 Revuforj approved in United States?

Yes. FDA authorised it on 15 November 2024; FDA has authorised it.

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

SYNDAX holds the US marketing authorisation.