Novo Nordisk obtains FDA approval for two prefilled insulin pens

Denmark-based medical device company Novo Nordisk has obtained the US Food and Drug Administration (FDA) approval for its NovoLog (insulin aspart [rDNA origin] injection) FlexTouch and Levemir (insulin detemir [rDNA origin] injection) FlexTouch prefilled insulin pens.

Novo Nordisk’s prefilled insulin delivery system FlexTouch features a push-button that does not extend at any set dose and allows insulin to be administered by pressing the low dose force button.

Novo Nordisk plans to launch the NovoLog FlexTouch and Levemir FlexTouch prefilled insulin pens in the US within the 2014.

In July 2011, the European Commission has approved FlexTouch and it was launched in several countries, including the UK, Canada, Denmark and Japan.

Novo Nordisk executive vice president and chief scientific officer Mads Krogsgaard Thomsen noted the company is committed to continuously introducing new solutions that can improve the lives of people with diabetes.

"This approval marks another advancement in insulin delivery and an important milestone for Novo Nordisk," Thomsen added.

The prefilled insulin pen NovoLog FlexTouch contains 300 units of insulin aspart and the pen doses in one unit increments, from 1-80 units.

Levemir FlexTouch contains 300 units of insulin detemir and the pen doses in one unit increments, from 1-80 units.

Both are compatible with NovoFine and NovoTwist needles.