FDA Approves Novo Nordisk’s Growth Hormone Treatment

3 March 2010 (Last Updated March 3rd, 2010 18:30)

The US Food and Drug Administration (FDA) has approved Norditropin FlexPro (somatropin [rDNA origin] injection), a pre-filled injection pen manufactured by Novo Nordisk to be used by children and adults with growth hormone disorders. The new treatment is designed for children who have gro

The US Food and Drug Administration (FDA) has approved Norditropin FlexPro (somatropin [rDNA origin] injection), a pre-filled injection pen manufactured by Novo Nordisk to be used by children and adults with growth hormone disorders.

The new treatment is designed for children who have growth failure because of low or no growth hormone; children who are short and who have Noonan syndrome or Turner syndrome; children who are short because they were born small and have not caught up in growth by ages two to four; and adults who do not make enough growth hormone.

Norditropin FlexPro has a user-friendly design that makes it easy to learn and use, as well as an audible click that confirms that the medication has left the pen.

Norditropin FlexPro also requires no reconstitution and no loading of cartridges.

Approval was based on a study designed to evaluate the usability of the product, in which 100% of patients found it easy to learn how to use the treatment, while 99% of patients found it easy to push the button to dose and 99% found it easy to inject their dose.