FDA Approves FlexPro PenMate

Novo Nordisk’s FlexPro PenMatehas received U.S. Food and Drug Administration approval, the company announced.

FlexPro PenMate is to be used exclusively with Norditropin FlexPro 5-, 10-, and 15-mg pens. Norditropin is a prescription medication that contains the human growth hormone somatropin (rDNA origin).

“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,” Eddie Williams, senior vice president of Biopharmaceuticals for Novo Nordisk, said in a press statement. “FlexPro PenMate was developed to hide the needle, demonstrating our commitment to keeping the patient at the center of everything we do.”

The Norditropin FlexPro pen fit inside of FlexPro PenMate. After it is put in the locked position, the needle can be attached. FlexPro PenMate conceals the needle and prevents patients from seeing it being inserted into their skin during injection.  

Norditropin is indicated for children who are not growing due to growth hormone deficiency, who have Noonan syndrome or Turner syndrome and are short in stature, and who were born small for gestational age and have not caught up in growth by ages 2 to 4 years. It is also approved for use in adults with either adult-onset or childhood-onset growth hormone deficiency.

The most common adverse effects of the medication include headaches, muscle pain, joint stiffness, hyperglycemia, and glucosuria. See the full prescribing information for additional information.

FlexPro PenMate is expected to be available throughout the United States later this year.

-Meredith Edwards White

Reference:

1. Novo Nordisk. Novo Nordisk receives FDA approval for FlexPro PenMate for people with growth hormone-related disorders. www.novonordisk-us.com. 2015 Jul 16.