Posts Tagged ‘insulin degludec’

February 11th, 2013

FDA Wants Cardiovascular Safety Data Before Approving Insulin Degludec

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 […]