Disaster in Novo Nordisk: Tresiba® (insulin degludec) - not approved by FDA!!!

It should be something very wrong with FDA or Tresiba or Novo Nordisk but the news is very serious:

NEW YORK — Novo Nordisk AS says the Food and Drug Administration rejected its applications for approval of once-per-day insulin drugs to treat diabetes.

 

The Danish drugmaker says it received a “complete response letter” from the FDA regarding its applications for approval of Tresiba and Ryzodeg, or insulin degludec, on Friday. Such a letter indicates the agency determined the application cannot be approved in its current form.

 

In November, panel of federal health advisers recommended that the government approve degludec. The FDA is not required to follow the group’s advice, but it often does.

Tresiba contains long-acting insulin, and Ryzodeg contains both long- and short-acting insulins.