FDA accepts Novo Nordisk's resubmitted application for insulin drug

April 7, 2015 8:15 PM

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FDA accepts Novo Nordisk's resubmitted application for insulin drug

(Reuters) - Denmark's Novo Nordisk A/S said the U.S. Food and Drug Administration accepted a resubmitted application for its key insulin drug, Tresiba, based on interim analysis data from a clinical trial.

Tresiba, already available outside the United States, was rebuffed by the FDA two years ago on concerns that the drug could be linked to higher rates of heart attacks or strokes.

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