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www.fdanews.com/articles/147315-fda-pushes-back-review-of-two-novo-nordisk-diabetes-candidates

FDA Pushes Back Review of Two Novo Nordisk Diabetes Candidates

June 19, 2012
Novo Nordisk will have to wait until late October to get word on the fate of two ultra-long-acting insulin treatments because the FDA needs additional time to review data clarifications and analyses it requested after the initial NDA submissions. The Danish drugmaker submitted a “substantial” amount of new data, and due to the size and timing of the submissions the agency considers them major amendments to the marketing applications, Novo Nordisk said.
Washington Drug Letter