🇺🇸 Aqneursa in United States

FDA authorised Aqneursa on 24 September 2024

Marketing authorisations

FDA — authorised 24 September 2024

Application: NDA219132
Marketing authorisation holder: INTRABIO
Indication: Type 1 - New Molecular Entity
Status: approved

The FDA approved Aqneursa, a new molecular entity, on 24 September 2024. The marketing authorisation was granted to INTRABIO under the standard expedited pathway. The approval was based on the application number NDA219132.

Read official source →

FDA

Marketing authorisation holder: INTRABIO
Status: approved

Aqneursa in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Aqneursa approved in United States?

Yes. FDA authorised it on 24 September 2024; FDA has authorised it.

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

INTRABIO holds the US marketing authorisation.