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®

PR Newswire

PLAINSBORO, N.J., Nov. 1, 2013

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PLAINSBORO, N.J., Nov. 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.

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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.
"Thisapproval 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)?

  oNovoLog^® 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^®?

  oDo 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^®?

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

How should I take NovoLog^®?

  oEat 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.
  oDo 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.
  oDo not change your dose or type of insulin unless you are told to by your
    health care provider.
  oDo not share needles, insulin pens, or syringes.
  oCheck your blood sugar levels as directed by your health care provider.

What should I consider while using NovoLog^®?

  oAlcohol, including beer and wine, may affect your blood sugar.
  oBe 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)?

  oLow 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.
  oSerious 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.
  oOther 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)?

  oLevemir^® is a man-made long-acting insulin used to control high blood
    sugar in adults and children with diabetes mellitus.
  oIt is not recommended to use Levemir^® to treat diabetic ketoacidosis.

Important Safety Information
Who should not use Levemir^®?

  oDo not use Levemir^® if you are allergic to any of its ingredients.

What should I tell my health care provider before taking Levemir^®?

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

How should I take Levemir^®?

  oInject Levemir^® under the skin of your stomach area, upper arms, or
    thighs, but never into a vein or muscle.
  oDo 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.
  oDo not change your dose or type of insulin unless you are told to by your
    health care provider.
  oDo not share needles, insulin pens, or syringes.
  oCheck your blood sugar levels as directed by your health care provider.

What should I consider while using Levemir^®?

  oAlcohol, including beer and wine, may affect your blood sugar.
  oBe 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^®?

  oLow 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.
  oSerious 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.
  oOther 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 diabetes[i], 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.

FlexPen^®, FlexTouch^®, Levemir^®, NovoLog^®, NovoFine^®, and NovoTwist^® are
registered trademarks of Novo Nordisk A/S.

© 2013 Novo Nordisk All rights reserved. 0813-00017799-1November 2013

[i] 2011 National Diabetes Fact Sheet. Centers for Disease Control Website.
http://www.cdc.gov/diabetes/pubs/factsheet11.htm

SOURCE Novo Nordisk

Website: http://www.novonordisk-us.com
Contact: Media: Katrine Sperling, Tel: (+45) 4442 6718, krsp@novonordisk.com;
In North America: Sarah Spielvogel, Tel: (+1) 609 786 4278,
sspv@novonordisk.com; Investors: Klaus Bulow Davidsen, Tel: (+45) 4442 3176,
klda@novonordisk.com; Frank Daniel Mersebach, Tel: (+45) 4442 0604,
fdni@novonordisk.com; Lars Borup Jacobsen, Tel: (+45) 3075 3479,
lbpj@novonordisk.com; Jannick Lindegaard, Tel: (+1) 609 786 4575,
jlis@novonordisk.com