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Novo Nordisk A/S (NVO) Grabs FDA OK for Kid-Friendly Insulin Injection Pen


8/22/2013 6:29:40 AM

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Novo Nordisk receives U.S. FDA clearance for the insulin injection device NovoPen Echo®

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.

To view the multimedia assets associated with this release, please click: http://www.multivu.com/mnr/62978-novo-nordisk-u-s-fda-approval-for-pre-filled-insulin-pen-novopen-echo

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)?

  • NovoLog® is a man-made insulin used to control high blood sugar in adults and children with diabetes mellitus.

Important Safety Information
Who should not use NovoLog®?

  • Do not use NovoLog® if your blood sugar is too low (hypoglycemia) or you are allergic to any of its ingredients.

What should I tell my health care provider before takingNovoLog®?

  • About all of your medical conditions, including liver, kidney, or heart problems.
  • If you are pregnant, breastfeeding, or plan to do either.
  • About all prescription and nonprescription medicines you take, including supplements, as your dose may need to change.

How should I take NovoLog®?

  • Eat a meal within 5 to 10 minutes after using NovoLog®, a fast-acting insulin, to avoid low blood sugar. Do not inject NovoLog® if you do not plan to eat right after your injection or bolus pump infusion.
  • Do not mix NovoLog® with any other insulin when used in a pump or with any insulin other than NPH when used with injections by syringe.
  • Do not change your dose or type of insulin unless you are told to by your health care provider.
  • Do not share needles, insulin pens, or syringes.
  • Check your blood sugar levels as directed by your health care provider.

What should I consider while using NovoLog®?

  • Alcohol, including beer and wine, may affect your blood sugar.
  • Be careful when driving a car or operating machinery. You may have difficulty concentrating or reacting if you have low blood sugar. Talk to your health care provider if you often have low blood sugar or no warning signs of low blood sugar.

What are the possible side effects of NovoLog® (insulin aspart [rDNA origin] injection)?

  • Low blood sugar, including when too much is taken. Some symptoms include sweating, shakiness, confusion, and headache. Severe low blood sugar can cause unconsciousness, seizures, and death.
  • Serious allergic reactions may occur. Get medical help right away, if you develop a rash over your whole body, have trouble breathing, a fast heartbeat, or sweating.
  • Other side effects include injection site reactions (like redness, swelling, and itching), skin thickening or pits at the injection site, swelling of your hands and feet, if taken with thiazolidinediones (TZDs) possible heart failure, vision changes, low potassium in your blood, and weight gain.

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.comor follow our news in the US on Twitter: @NovoNordiskUS.

About Diabetes
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:

Media:
Sarah Spielvogel
Novo Nordisk
609-786-4278
sspv@novonordisk.com

Investors:
Jannick Lindegaard
609-786-4575
jlis@novonordisk.com

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



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