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Regulatory strategy

The Swedish Medical Products Agency approved ISICORT® 2020 in Sweden. AcuCort intends to apply for further authorization within the EU through the mutual recognition procedure (MRP). The registration process for the Nordic market is ongoing and applications were submitted in 2021. The Danish Medicines Agency, Laegemiddelstyrelsen approved in 2022 the same drug under the name Zeqmelit in Denmark.

AcuCort has identified a regulatory strategy for approval in the US and an initial Pre-NDA (New Drug Application) meeting with the U.S. Food and Drug Administration (FDA) has taken place. A continued dialogue is underway with the aim of maximizing the likelihood of a quick and positive treatment of the company’s application once it has been submitted.