FDA posts briefing materials prior to Advisory Committee meeting for insulin degludec and insulin degludec/insulin aspart (6 November 2012)
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Bagsværd, Denmark, 6 November 2012 Novo Nordisk announced today that the US Food and Drug Administration (FDA) has published the briefing documents ahead of the Advisory Committee meeting to discuss the New Drug Applications (NDA) for insulin degludec and insulin degludec/insulin aspart, which will take place on 8 November 2012.
The briefing documents from Novo Nordisk and the FDA, which will form the basis for the Advisory Committee's discussion, provide an overview of the non-clinical and clinical data for insulin degludec and insulin degludec/insulin aspart for the treatment of diabetes.
The briefing materials can be accessed on the FDA webpage here
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Company Announcement no. 71 2012