Novo Nordisk Receives U.S. FDA approval for NovoLog® FlexTouch® and Levemir® FlexTouch®

Novo Nordisk Receives U.S. FDA approval for NovoLog® FlexTouch® and Levemir® FlexTouch®

Plainsboro, N.J. (November 1, 2013) /PRNewswire/ — Novo Nordisk, a world leader in diabetes care, today announced that the U.S. Food and Drug Administration (FDA) has approved the prefilled insulin pens NovoLog® (insulin aspart [rDNA origin] injection) FlexTouch® and Levemir® (insulin detemir [rDNA origin] injection) FlexTouch®. FlexTouch® is a new prefilled insulin delivery system from Novo Nordisk.

When a dose is dialed with traditional prefilled pens, the push button extends, and at larger doses this can present challenges for the patient. The unique dosing mechanism of FlexTouch® ensures the push-button does not extend at any dose and allows insulin to be administered by pressing the low dose force button.

"Novo Nordisk is committed to continuously introducing new solutions that can improve the lives of people with diabetes," said Mads Krogsgaard Thomsen, executive vice president and chief scientific officer of Novo Nordisk. "This approval marks another advancement in insulin delivery and an important milestone for Novo Nordisk."

Novo Nordisk plans to make NovoLog® FlexTouch® and Levemir® FlexTouch® available in the U.S. within the next year. FlexTouch® was approved by the European Commission in July 2011 and has launched in several countries, including the United Kingdom, Canada, Denmark and Japan.

For more information on Novo Nordisk products, please visit www.novonordisk-us.com.

About NovoLog® FlexTouch®
NovoLog® FlexTouch® is a prefilled insulin pen containing 300 units of insulin aspart. The pen doses in 1 unit increments, from 1 to 80 units and is compatible with both NovoFine® and the latest NovoTwist® needles.

NovoTwist® comes in 5 mm (32G Tip) and 8 mm (30G) versions. An audible and tactile 'click' confirms attachment of the needle.

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 Levemir® FlexTouch®
Levemir® FlexTouch® is a prefilled insulin pen containing 300 units of insulin detemir. The pen doses in 1 unit increments, from 1 to 80 units and is compatible with both NovoFine® and the latest NovoTwist® needles.

NovoTwist® comes in 5 mm (32G Tip) and 8 mm (30G) versions. An audible and tactile 'click' confirms attachment of the needle.

Indications and Usage
What is Levemir® (insulin detemir [rDNA origin] injection)?
Levemir® is a man-made long-acting insulin used to control high blood sugar in adults and children with diabetes mellitus.
It is not recommended to use Levemir® to treat diabetic ketoacidosis.
Important Safety Information
Who should not use Levemir®?
Do not use Levemir® if you are allergic to any of its ingredients.
What should I tell my health care provider before taking Levemir®?
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 Levemir®?
Inject Levemir® under the skin of your stomach area, upper arms, or thighs, but never into a vein or muscle.
Do not dilute or mix Levemir® with any other insulin or injectable diabetes medicine or use in an insulin pump. Give yourself separate injections in the same body area, but not next to each other.
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 Levemir®?
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 Levemir®?
Low blood sugar (hypoglycemia), 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, if taken with thiazolidinediones (TZDs) possible heart failure, and weight gain.
Please visit levemir.com for Prescribing Information.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare 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 www.novonordisk-us.com.

About Diabetes
In the United States, 25.8 million people have diabetesi, 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.

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