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FDA Approves NovoLog(R) Labeling Update

Jul 21, 2009
 

Diabetes patients taking NovoLog((R)) (insulin aspart [rDNA origin] injection) can now use the insulin in their pump for up to six days following the FDA approval of a labeling change. Novo Nordisk announced last week that this makes NovoLog((R)) the first and only rapid-acting insulin with this extended in-use time.

 

The updated NovoLog((R)) label also states that patients using NovoLog((R)) in their pumps should change the infusion set and the infusion set insertion site at least every three days. The revised label keeps the same recommendation that NovoLog((R)) should be discarded after exposure to temperatures that exceed 37 degrees C (98.6 degrees F).

 

Richard R. Rubin, PhD, professor, medicine and pediatrics, The Johns Hopkins University School of Medicine stated that, “The ability to go longer between changes of insulin in the pump allows people with diabetes to have more active and flexible lifestyles, which are integral to the success of long-term diabetes management.”

The label change is based on the FDA’s review of data from Novo Nordisk that showed the stability of NovoLog((R)) in the pump for up to six days.

NovoLog((R)) is a rapid-acting insulin analog, meaning it works faster and for a shorter period of time compared with regular human insulin. NovoLog((R)) is also available in FlexPen((R)), the world’s number one selling prefilled insulin pen. Diabetes patients who take NovoLog((R)) can eat within 5-10 minutes of use, rather than the typical 30 minutes required with regular human insulin.

Novo Nordisk news release