Novo Nordisk Receives FDA Approval for Norditropin® FlexPro® 30 mg/3.0 mL for Patients with Growth Hormone Disorders

Norditropin® FlexPro® 30 mg/3.0 mL offers an additional option for patients who may require a higher dose of treatment

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Jan 26, 2015, 07:40 ET

PLAINSBORO, N.J., Jan. 26, 2015 /PRNewswire/ -- Novo Nordisk announced today the U.S. Food and Drug Administration (FDA) approval of Norditropin^® (somatropin [rDNA origin] injection) FlexPro^®30 mg/3.0 mL, a prefilled injection pen for patients with growth hormone-related disorders. The FlexPro^®30 mg/3.0 mL device complements the existing portfolio of Norditropin^®FlexPro^®products available in 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL pens.

"Novo Nordisk is committed to advancing growth hormone delivery devices with patients in mind," said Eddie Williams, senior vice president, Biopharmaceuticals, Novo Nordisk. "This approval marks another option for patients who may need higher doses of treatment."

The availability of four different strengths of Norditropin^® FlexPro^®enhances physicians' ability to better address the unique needs of appropriate patients on treatment. Each Norditropin^® FlexPro^®pen is prefilled with Norditropin^®, and is color coded to differentiate the various strengths. Novo Nordisk plans to make Norditropin^® FlexPro^®30 mg/3.0 mL available by April 2015.

Visit www.norditropin.com for more information on Norditropin^®.

Indications and Usage
What is Norditropin^® (somatropin [rDNA origin] injection)?

Norditropin^® is a prescription medicine that contains human growth hormone and is used to treat:

children who are not growing because of low or no growth hormone.
children who are short (in stature) and who have Noonan syndrome or Turner syndrome.
children who are short (in stature) because they were born small (small for gestational age-SGA) and have not caught-up in growth by age 2 to 4 years.
adults who did not make enough growth hormone when they were children or when they became adults.

Important Safety Information
Who should not use Norditropin^®?
Do not use Norditropin^® if:

you have a critical illness caused by certain types of heart or stomach surgery, trauma or breathing (respiratory) problems.
you are a child with Prader-Willi syndrome who is severely obese or has breathing problems including sleep apnea.
you have cancer or other tumors.
your healthcare provider tells you that you have certain types of eye problems caused by diabetes.
you are a child with closed bone growth plates (epiphyses).
you are allergic to any of the ingredients in Norditropin^®.

What should I tell my healthcare provider before I start Norditropin^®?
Tell your healthcare provider if you:

have diabetes, had cancer or any tumor, or have any other medical conditions.
are pregnant or breastfeeding, or plan to become pregnant or breastfeed.
take any prescription and non-prescription medicines, vitamins or herbal supplements. Norditropin^® may affect how other medicines work, and other medicines may affect how Norditropin^® works.

How should I use Norditropin^®?
Do not share your Norditropin^® pen and needles with another person. You may give another person an infection or get an infection from them.

What are the possible side effects of Norditropin^®?
Norditropin^® can cause serious side effects, including:

high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.
high risk of death in children with Prader-Willi syndrome who are severely obese or have breathing problems including sleep apnea.
return of tumor or cancerous growths.
high blood sugar (hyperglycemia).
increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting, swollen hands and feet due to fluid retention contact your healthcare provider right away.
decrease in thyroid hormone levels.
hip and knee pain or a limp in children (slipped capital femoral epiphysis).
worsening of pre-existing curvature of the spine (scoliosis).
middle ear infection, hearing or ear problems in patients with Turner syndrome.
redness, itching and tissue weakness in the area of skin you inject.
increase in phosphorus, alkaline phosphatase, and parathyroid hormone levels in your blood.

The most common side effects of Norditropin^® include:

headaches, muscle pain, joint stiffness, high blood sugar (hyperglycemia), and sugar in your urine (glucosuria).

Please click here for Norditropin^® Prescribing Information.

Norditropin^® is a prescription medication.

Novo Nordisk provides patient assistance for those who qualify. Please call 1-866-310-7549 to learn more about Novo Nordisk assistance programs.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Talk to your healthcare provider and find out if Norditropin^® is right for you or your child.

About Novo Nordisk
Headquartered in Denmark, Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. The company also has leading positions within haemophilia care, growth hormone therapy and hormone replacement therapy. Novo Nordisk employs approximately 41,000 employees in 75 countries, and markets its products in more than 180 countries. For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn, YouTube.

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