Novo Nordisk A/S Receives FDA Approval for Norditropin(R) FlexPro(R) for Growth Hormone Treatment

PRINCETON, N.J., March 3 /PRNewswire/ -- Novo Nordisk announced today that the U.S. Food and Drug Administration (FDA) has approved Norditropin(R) FlexPro(R) (somatropin [rDNA origin] injection), a pre-filled injection pen to be used by children and adults with growth hormone disorders. It will be available in the second quarter.

Norditropin(R) FlexPro(R) has a user friendly design which makes it easy to learn and use, and an audible click that confirms that the medication has left the pen. Norditropin(R) FlexPro(R) requires no reconstitution and no loading of cartridges. Norditropin(R) FlexPro(R) is available in 5 mg/1.5 mL, 10 mg/1.5 mL and 15 mg/1.5 mL pens. After first use, the 5 mg/1.5 mL and 10 mg/1.5 mL pens may be left at room temperature for up to three weeks without risk of spoilage.

“Easy to use, growth hormone delivery devices allow patients and health care professionals alike to benefit from the convenience of these pens,” said Dr. Pinchas Cohen, professor of pediatrics at the David Geffen School of Medicine at UCLA and chief of endocrinology at the Mattel Children’s Hospital at UCLA.

The introduction of Norditropin(R) FlexPro(R) represents the latest advance in growth hormone devices from Novo Nordisk. Patients can receive support and training for Norditropin(R) FlexPro(R) through the NordiCare(R) program.

About Norditropin(R)

Norditropin(R) (somatropin [rDNA origin] injection) is used to treat: children who have growth failure 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; and adults who do not make enough growth hormone.

Before you take Norditropin(R), tell your healthcare provider if you: have diabetes; had cancer or any tumor; have any other medical condition; are pregnant or plan to become pregnant; are breast-feeding or plan to breast-feed.

Patients with Noonan syndrome and Turner syndrome should be closely monitored by their doctors as they are more likely to have congenital heart disease.

If you have headaches, eye problems, nausea or vomiting, contact your healthcare provider right away.

Especially tell your healthcare provider if you take: glucocorticoid medication, thyroid hormone, insulin or other medicine for diabetes, medicines that are metabolized by the liver (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement medicine.

About Novo Nordisk

Headquartered in Denmark, Novo Nordisk is a global healthcare company with 87 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 novonordisk-us.com.

CONTACT: Media: Ambre Morley, +1-609-987-5898, or Investors:, Hans Rommer,
+45-4442-4765

Web site: http://www.novonordisk-us.com/

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