Novo Nordisk receives complete response letter in the US for once weekly basal insulin icodec

Novo Nordisk

10 July 2024 - Novo Nordisk today announced that the US FDA has issued a complete response letter covering the Biologics License Application for once weekly basal insulin icodec for the treatment of diabetes mellitus.

In the letter, the FDA has requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed.

Read Novo Nordisk press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Dossier