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Regulatory strategy

In October 2020, the Swedish Medical Products Agency approved ISICORT®. 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.

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. At the end of the year, an active dialogue was underway with the aim of maximizing the likelihood of a quick and positive treatment of the company’s application once it has been submitted.