Aug 21, 2013
PLAINSBORO, N.J., Aug. 21, 2013 /PRNewswire/ -- Novo Nordisk, a world leader in diabetes care, announced today that the U.S. Food and Drug Administration (FDA) has granted 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.
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This pen is the latest insulin delivery system from Novo Nordisk, and will be available to patients for use with NovoLog® (insulin aspart [rDNA origin] injection) PenFill® cartridges.
"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."
Half-unit dose increments allow for finer adjustments, which can be particularly important for children. In addition, different removable skins will be available for a kid-friendly customized look.
Novo Nordisk plans to make NovoPen Echo® available in the U.S. in early 2014. NovoPen Echo® has already launched in Europe, Canada, and Israel.
For more information on Novo Nordisk products, please visit www.novonordisk-us.com.
Please see updated Important Safety Information below, including use with thiazolidinediones (TZDs).
Indications and Usage
What is NovoLog® (insulin aspart [rDNA origin] injection)?
Important Safety Information
Who should not use NovoLog®?
What should I tell my health care provider before taking NovoLog®?
How should I take NovoLog®?
What should I consider while using NovoLog®?
What are the possible side effects of NovoLog® (insulin aspart [rDNA origin] injection)?
Please visit novolog.com for Prescribing Information.
About Novo Nordisk
Headquartered in Denmark, 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. For more information, visit novonordisk-us.com or follow our news in the US on Twitter: @NovoNordiskUS.
In the United States, 25.8 million people have diabetes,1 a condition in which the body does not produce enough or properly use insulin, the hormone needed to convert sugar, starches and other food into energy needed for daily life.
For further information, please contact:
NovoPen Echo®, NovoLog® and PenFill® are registered trademarks of Novo Nordisk A/S.
© 2013 Novo Nordisk All rights reserved. 0813-00017645-1 August 2013
1 2011 National Diabetes Fact Sheet. Centers for Disease Control. http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf. Accessed August 14, 2013.
SOURCE Novo Nordisk