March 18, 2008 - Novo Nordisk (NYSE: NVO) announced that the U.S. Food and Drug Administration has approved NovoLog® (insulin aspart [rDNA origin] injection) for continuous subcutaneous insulin infusion (CSII) by external insulin pump in pediatric patients between the ages of 4 and 18 years. NovoLog® is the first and only insulin analog approved for this use. Data from a trial published in the February issue of Diabetes Care in support of this approval demonstrated that compared to insulin lispro CSII, NovoLog® CSII achieved similar levels of glycemic control and safety. Results came from a 16-week, open-label, multi-center, parallel group study of 298 patients (aspart, n= 198; lispro, n = 100) (aged 4-18 years; type 1 diabetes duration greater than or equal to 1 year; CSII therapy treatment greater than or equal to 3 months; A1C less than or equal to 10% at screening)... Novo Nordisk's press Release -
