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news.Denmark-based healthcare company Novo Nordisk has announced the FDA approval of Norditropin for the treatment of short stature in children born small for gestational age with no catch-up growth by age two to four years.
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The FDA approved Norditropin based on data from a 13-year clinical trial in children small for gestational age (SGA). The study showed that 63% of children who reached adult height were in the normal range of their peers.
Eddie Williams, vice president of biopharmaceuticals at Novo Nordisk, said: “In the past two years, Novo Nordisk has made Norditropin available to a wider range of patients through the approval of three indications: treatment of children with short stature associated with Noonan syndrome, treatment of children with short stature associated with Turner syndrome, and now, the treatment of patients born SGA.”