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Wednesday, The FDA Issued A Complete Response Letter Covering Novo Nordisk's Biologics License Application For Once-weekly Basal Insulin Icodec For Diabetes Mellitus

Author: Benzinga Newsdesk | July 11, 2024 06:13am

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. Novo Nordisk is evaluating the content of the CRL and will work closely with the FDA to fulfil the requests. Novo Nordisk does not expect to be able to fulfil the requests during 2024.

Posted In: NVO


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