FDA clears NovoPen Echo® Insulin Injection Device

Diabetes care specialist company Novo Nordisk, has seen the FDA grant it 510(k) clearance for the insulin device NovoPen Echo®. This marks the first and only pen device in the U.S. with half-unit dosing and a memory function that records the dose and time passed since the last injection.

Background

Novo Nordisk is a global health care company with 90 years of innovation and leadership in diabetes care. The company also has leading positions within hemophilia care, growth hormone therapy and hormone replacement therapy.

The NovoPen Echo is the latest insulin delivery system from the company and will be available to patients for use with NovoLog® (insulin aspart [rDNA origin] injection) PenFill® cartridges.

Novo Nordisk says it plans to make NovoPen Echo® available in the U.S. in early 2014. NovoPen Echo® has already launched in Europe, Canada, and Israel.

Company comments

“The U.S. approval of NovoPen Echo® represents a significant milestone in insulin delivery, especially for children with diabetes and their caregivers,” said Camille Lee, senior vice president, Diabetes Marketing at Novo Nordisk. “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.”

Source: Novo Nordisk, PR Newswire