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FDA Delays Approval of Novo Nordisk’s Once-Weekly Insulin Icodec

Novo Nordisk does not expect to be able to fulfill the FDA’s requests during 2024.

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By: Charlie Sternberg

Associate Editor

The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to Novo Nordisk covering the Biologics License Application for once-weekly basal insulin icodec for the treatment of diabetes mellitus. In the letter, the FDA makes requests related to the manufacturing process and the type 1 diabetes indication before the review of the application can be completed. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests. ...

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