Novo Nordisk Receives FDA Approval for FlexPro® PenMate® for People with Growth Hormone-Related Disorders

FlexPro® PenMate® designed for Norditropin® (somatropin [rDNA origin] injection) patients who dislike needles

PLAINSBORO, N.J., July 16, 2015 /PRNewswire/ -- Novo Nordisk announced today the U.S. Food and Drug Administration (FDA) approval of FlexPro® PenMate®, designed for users of Norditropin® FlexPro® 5 mg, 10 mg, and 15 mg pens who dislike needles and prefer them to be hidden during the injection process.

"Children and adolescents with growth hormone-related disorders are the primary users of Norditropin®, and some feel uneasy at the thought of having to inject their medicine," said Eddie Williams, senior vice president, Biopharmaceuticals, Novo Nordisk.  "FlexPro® PenMate® was developed to hide the needle, demonstrating our commitment to keeping the patient at the center of everything we do."

FlexPro® PenMate® has been developed exclusively for use with the Norditropin® FlexPro® 5, 10, and 15 mg pens.  It is a cylindrical attachment that is designed to conceal the needle so patients cannot see it being inserted into their skin during injection.  The Norditropin® FlexPro® pen slides into FlexPro®PenMate® and twists into a locked position.  The needle is then attached, and the injection process can begin.  FlexPro® PenMate® features a large gripping surface so patients can firmly hold the pen during injection.

Norditropin® FlexPro® is the only prefilled growth hormone injection pen that can be stored outside of the refrigerator for up to 21 days after first usea.

Novo Nordisk expects to make FlexPro® PenMate® available in the United Statesin the latter half of this year.  Visit www.norditropin.com for more information on Norditropin®.

aAll Norditropin® products must be refrigerated prior to first use.  Do not freeze. After initial use, Norditropin® pens can either be stored outside of the refrigerator (up to 77 degrees F [25 degrees C]) for use within 3 weeks, or in the refrigerator (between 36 degrees F and 46 degrees F [2 degrees C and 8 degrees C]) for use within 4 weeks.

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.