FDA turns down two Novo Nordisk insulin products
BAGSVÆRD, Denmark — The Food and Drug Administration declined to approve two insulin products made by Danish drug maker Novo Nordisk, the company said Sunday.
Novo Nordisk said it received complete response letters from the FDA for Tresiba (insulin degludec) and Ryzodeg (insulin degludec and insulin aspart). The FDA issues a complete response letter when it has finished reviewing an application for a drug, but determines that the application can't be approved in its current form.
Reuters reported Monday the FDA had requested additional clinical trial data before it would consider approving Tresiba and Ryzodeg, but the company would not able able to provide the data in 2013 or 2014.