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FDA clears Novo Nordisk insulin pen for children

NovoPen Echo, with half dosing, receives FDA's 510k clearance

PLAINSBORO, N.J. — The Food and Drug Administration has given the green light to an insulin pen made by Novo Nordisk for half-unit dosing, the drug maker said Wednesday.

The Denmark-based drug maker announced the clearance of the NovoPen Echo, saying it marked the first and only pen device in the United States with half-unit dosing and a memory function that records the dose and time passed since the last injection. The system will be available for patients using NovoLog (insulin aspart [rDNA origin]) PenFill cartridges. Half-unit dose increments allow for finer adjustments, which can be important for children.

"The U.S. approval of NovoPen Echo represents a significant milestone in insulin delivery, especially for children with diabetes and their caregivers," Novo Nordisk SVP diabetes marketing Camille Lee said. "The pen can offer caregivers increased confidence that their children are managing their diabetes appropriately away from home by allowing them to see the amount and time passed since their last dose."

The pen is scheduled to become available in the United States early next year and is already on the market in Canada, Europe and Israel.

 

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