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 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.

Suggested Articles

RNA nanoparticles can squeeze into tumors and exit swiftly through the kidney, perfect for targeted delivery of cancer drugs, an OSU team says.

J&J figures its partner Genmab owes a share of Darzalex Faspro royalties to Halozyme for its subcutaneous delivery tech. Genmab doesn't agree.

Bexson Biomedical and Stevanato Group teamed up to develop a ketamine pump that may help patients better manage pain at home.