🇺🇸 Avmapki Fakzynja Co-Pack in United States

FDA authorised Avmapki Fakzynja Co-Pack on 8 May 2025

Marketing authorisations

FDA — authorised 8 May 2025

  • Application: NDA219616
  • Marketing authorisation holder: VERASTEM INC
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Avmapki Fakzynja Co-Pack, a new molecular entity, on 8 May 2025. The marketing authorisation holder is VERASTEM INC. The approval was granted through the standard expedited pathway. The indication approved for Avmapki Fakzynja Co-Pack is Type 1, which is a new molecular entity.

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FDA

  • Marketing authorisation holder: VERASTEM INC
  • Status: approved

Avmapki Fakzynja Co-Pack 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 Avmapki Fakzynja Co-Pack approved in United States?

Yes. FDA authorised it on 8 May 2025; FDA has authorised it.

Who is the marketing authorisation holder for Avmapki Fakzynja Co-Pack in United States?

VERASTEM INC holds the US marketing authorisation.