Novo Nordisk files for regulatory approval of the ultra-long-acting insulins Degludec and DegludecPlus in Europe (26 September 2011)
Novo Nordisk today announced the submission to the European Medicines Agency of two marketing authorisation applications for the approval of ultra-long acting insulin Degludec and the insulin combination analogue DegludecPlus, respectively. This new generation of insulins has been developed for the treatment of people with type 1 and type 2 diabetes.
Novo Nordisk expects to file the two new drug applications for Degludec and DegludecPlus to the US Food and Drug Administration within two weeks.