February 11th, 2013
FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec
Larry Husten, PHD
The FDA informed Novo Nordisk on Friday that it would not approve the company’s highly anticipated long-acting insulin degludec products (Tresiba and Ryzodeg) until it receives data from a cardiovascular outcomes trial. Approval of the drugs had been widely anticipated for this year, following a positive recommendation from an FDA advisory committee last fall. But the committee […]
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