FDA approves pediatric indication for Norditropin

November 6, 2008

The FDA has approved Novo Nordisk's Norditropin for the treatment of short stature in children who are small for gestational age (SGA) with no catch-up growth by age 2 to 4.

The FDA has approved Novo Nordisk's Norditropin for the treatment of short stature in children who are small for gestational age (SGA) with no catch-up growth by age 2 to 4.

The approval is based on data from a 13-year clinical trial of children with SGA. Results from the study showed that 63% of children who reached adult height were in the normal range of their peers.

Nortitropin (somatropin [rDNA origin] injection) is indicated for the treatment of children with short stature associated with Noonan syndrome or 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, according to manufacturer Novo Nordisk.