Danish drugmaker Novo Norkisk´s Norditropin injection (somatropin, rDNA origin) for the treatment of short stature in children born Small for Gestational Age (SGA) with no catch-up growth by age 2-4 years, has been approved for marketing in the U.S. by the Food and Drug Administration (FDA).

The U.S. health authorities approved Norditropin based on data from a 13-year clinical trial in children SGA, which showed that 63 percent of children treated who reached adult height were in the normal range of their peers.

Approximately 100,000 children in the U.S. are born annually with this condition. At birth, babies diagnosed SGA weigh less than approximately 97 percent of all other babies of the same gestational age, regardless of whether or not they are born premature. SGA may be caused by fetal abnormalities, placental insufficiency, and maternal factors. Some of these children will not catch up with the normal growth rates by the time they turn two.

Children diagnosed SGA may also be at increased risk of developing a number of long-term health consequences, including obesity, insulin resistance, carbohydrate intolerance, dyslipidemia, and psychosocial disadvantages. If untreated, SGA children account for nearly 15 percent of short adults.

Norditropin (somatropin, rDNA origin) is indicated for the treatment of children with short stature associated with Noonan syndrome, treatment of children with short stature associated with Turner Syndrome, treatment of children with growth failure due to inadequate secretion of endogenous growth hormone, and treatment of short stature in children born SGA with no catch-up growth by age 2.
In the first nine months of 2008, Norditropin had sales of $ 532 million dollars.