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.
Media:
|
|
|
Katrine
Sperling
|
+45 3079 6718
|
krsp@novonordisk.com
|
Ken Inchausti
(US)
|
+1 609 514 8316
|
kiau@novonordisk.com
|
|
|
|
Investors:
|
|
|
Kasper Roseeuw
Poulsen
|
+45 3079 4303
|
krop@novonordisk.com
|
Jannick Lindegaard
Denholt
|
+45 3079 8519
|
jlis@novonordisk.com
|
Lars Borup
Jacobsen
|
+45 3075 3479
|
lbpj@novonordisk.com
|
Daniel
Bohsen
|
+45 3079 6376
|
dabo@novonordisk.com
|
Frank Daniel
Mersebach (US)
|
+1 609 235 8567
|
fdni@novonordisk.com
|
© 2015 Novo Nordisk All rights reserved. 1114-00023985-1 January
2015
Logo -
http://photos.prnewswire.com/prnh/20110414/NY80976LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/novo-nordisk-receives-fda-approval-for-norditropin-flexpro-30-mg30-ml-for-patients-with-growth-hormone-disorders-300025960.html
SOURCE Novo Nordisk