🇺🇸 Dawnzera in United States

FDA authorised Dawnzera on 21 August 2025

Marketing authorisations

FDA — authorised 21 August 2025

  • Application: NDA219407
  • Marketing authorisation holder: IONIS PHARMS INC
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

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FDA

  • Marketing authorisation holder: IONIS PHARMS INC
  • Status: approved

Dawnzera in other countries

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

Other Pain approved in United States

Frequently asked questions

Is Dawnzera approved in United States?

Yes. FDA authorised it on 21 August 2025; FDA has authorised it.

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

IONIS PHARMS INC holds the US marketing authorisation.