Novo Nordisk receives U.S. FDA clearance for the insulin injection device NovoPen Echo® First insulin injection device to combine half-unit dosing with a memory function to help patients better manage their diabetes
Plainsboro, NJ, /PRNewswire/
Novo Nordisk 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.
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.
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.
- 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.
- 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.
- 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.
- 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.