BRIEF—FDA approves additional indications for Zomacton

21 July 2018

Privately-held Swiss drugmaker Ferring Pharmaceuticals says the US Food and Drug Administration has approved Zomacton (somatropin) for injection in four additional pediatric indications:

  • Idiopathic short stature (ISS)
  • Short stature associated with Turner syndrome
  • Short stature born small for gestational age (SGA) with no catch-up growth by 2 to 4 years
  • Short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency

Zomacton was previously approved to treat growth failure in pediatric patients due to inadequate secretion of endogenous growth hormone (GH) and replacement of endogenous GH in adults with GH deficiency.

Along with these approvals, Ferring announced plans to launch the ZOMA-Jet 10Needle-Free Delivery System for Zomacton in September.

It is estimated that around 3%-5% of children in the USA have short stature, defined as a height below the 3rd percentile. Patients with short stature typically present with below average height in relation to their age, sex, racial group, or family.



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