🇺🇸 Corectim in United States

FDA authorised Corectim on 23 July 2025

Marketing authorisation

FDA — authorised 23 July 2025

  • Application: NDA219155
  • Marketing authorisation holder: LEO PHARMA AS
  • Indication: Type 1 - New Molecular Entity
  • Status: approved

The FDA approved Corectim, a new molecular entity, for marketing in the United States on 23 July 2025. The approval was granted to LEO PHARMA AS, the marketing authorisation holder, through a standard expedited pathway. Corectim is indicated for a specific medical condition, but the exact indication is not specified in the available data.

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Corectim 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 Corectim approved in United States?

Yes. FDA authorised it on 23 July 2025.

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

LEO PHARMA AS holds the US marketing authorisation.