A new indication for omnitrope approved

September 1, 2010

The Food and Drug Administration has approved the human growth hormone Omnitrope (somatropin - rDNA origin) for the treatment of idiopathic short stature.

The Food and Drug Administration (FDA) has approved the human growth hormone Omnitrope (somatropin [rDNA origin]) for the treatment of idiopathic short stature.

This approval follows other recent approvals for Omnitrope for the treatment of children who have Prader-Willi Syndrome and those who are small for gestational age, in addition to treatment of growth failure in pediatric patients and as replacement therapy in adults with growth hormone deficiency.

Idiopathic short stature, also called nongrowth hormone deficient short stature, is a term used to describe children or adolescents who are very short compared with others of their age but who have no identifiable disorder or no evidence of systemic, endocrine, nutritional, or chromosomal abnormalities. Children with idiopathic short stature represent the shortest of 2.3% of children, and about 60% to 80% of all short children who fit the criteria can be said to have the condition.