🇺🇸 Vanrafia in United States

FDA authorised Vanrafia on 2 April 2025

Marketing authorisations

FDA — authorised 2 April 2025

  • Application: NDA219208
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: VANRAFIA
  • Indication: TABLET — ORAL
  • Status: approved

The FDA approved Vanrafia, a medication developed by Novartis, for its approved indication on 20 October 2025. The application number for this approval is NDA219208. Vanrafia was granted marketing authorisation through the standard expedited pathway.

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FDA

  • Marketing authorisation holder: NOVARTIS
  • Status: approved

Vanrafia in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Immunology approved in United States

Frequently asked questions

Is Vanrafia approved in United States?

Yes. FDA authorised it on 2 April 2025; FDA has authorised it.

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

NOVARTIS holds the US marketing authorisation.