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Novo Nordisk Gets Complete Response Letter from US FDA for Insulin Icodec Application
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Novo Nordisk Gets Complete Response Letter from US FDA for Insulin Icodec Application
Jul 11, 2024 3:28 AM

06:09 AM EDT, 07/11/2024 (MT Newswires) -- Novo Nordisk ( NVO ) said Wednesday that it has received a complete response letter from the US Food and Drug Administration regarding the company's biologics license application for insulin icodec as treatment of diabetes mellitus.

The company said the letter includes requests related to insulin icodec's manufacturing process and its type 1 diabetes indication before the application review can be completed.

Novo Nordisk ( NVO ) said it does not expect to fulfill the requests within this year.

Price: 141.72, Change: -1.02, Percent Change: -0.71

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