Welcome!

News Feed Item

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, 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 taking NovoLog®?

  • 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.com or 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
[email protected]

Investors:
Jannick Lindegaard
609-786-4575
[email protected]

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

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
SYS-CON Events announced today that EARP will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. "We are a software house, so we perfectly understand challenges that other software houses face in their projects. We can augment a team, that will work with the same standards and processes as our partners' internal teams. Our teams will deliver the same quality within the required time and budget just as our partn...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 20th Cloud Expo, which will take place on June 6-8, 2017 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 add...
SYS-CON Events announced today that Tappest will exhibit MooseFS at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. MooseFS is a breakthrough concept in the storage industry. It allows you to secure stored data with either duplication or erasure coding using any server. The newest – 4.0 version of the software enables users to maintain the redundancy level with even 50% less hard drive space required. The software func...
Most technology leaders, contemporary and from the hardware era, are reshaping their businesses to do software in the hope of capturing value in IoT. Although IoT is relatively new in the market, it has already gone through many promotional terms such as IoE, IoX, SDX, Edge/Fog, Mist Compute, etc. Ultimately, irrespective of the name, it is about deriving value from independent software assets participating in an ecosystem as one comprehensive solution.
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @ThingsExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.
Amazon started as an online bookseller 20 years ago. Since then, it has evolved into a technology juggernaut that has disrupted multiple markets and industries and touches many aspects of our lives. It is a relentless technology and business model innovator driving disruption throughout numerous ecosystems. Amazon’s AWS revenues alone are approaching $16B a year making it one of the largest IT companies in the world. With dominant offerings in Cloud, IoT, eCommerce, Big Data, AI, Digital Assista...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
SYS-CON Events announced today that Systena America will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Systena Group has been in business for various software development and verification in Japan, US, ASEAN, and China by utilizing the knowledge we gained from all types of device development for various industries including smartphones (Android/iOS), wireless communication, security technology and IoT serv...
SYS-CON Events announced today that Outscale will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outscale's technology makes an automated and adaptable Cloud available to businesses, supporting them in the most complex IT projects while controlling their operational aspects. You boost your IT infrastructure's reactivity, with request responses that only take a few seconds.
Everywhere we turn in our industry we can find strong opinions about the direction, type and nature of cloud’s impact on computing and business. Another word that is used in every context in our industry is “hybrid.” In his session at 20th Cloud Expo, Alvaro Gonzalez, Director of Technical, Partner and Field Marketing at Peak 10, will use a combination of a few conceptual props and some research recently commissioned by Peak 10 to offer a real-world consideration of how the various categories of...
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
DevOps at Cloud Expo – being held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real r...
Cloud applications are seeing a deluge of requests to support the exploding advanced analytics market. “Open analytics” is the emerging strategy to deliver that data through an open data access layer, in the cloud, to be directly consumed by external analytics tools and popular programming languages. An increasing number of data engineers and data scientists use a variety of platforms and advanced analytics languages such as SAS, R, Python and Java, as well as frameworks such as Hadoop and Spark...
Cloud promises the agility required by today’s digital businesses. As organizations adopt cloud based infrastructures and services, their IT resources become increasingly dynamic and hybrid in nature. Managing these require modern IT operations and tools. In his session at 20th Cloud Expo, Raj Sundaram, Senior Principal Product Manager at CA Technologies, will discuss how to modernize your IT operations in order to proactively manage your hybrid cloud and IT environments. He will be sharing bes...
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...