U.S. License Holder:
Date of License:
OMNITROPE (somatropin) is a recombinant human growth hormone indicated for:
Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature;
Adult: Treatment of adults with either adult onset or childhood onset GHD.
Approved Foreign Follow-On Biologics / Biosimilars
Biosimilars Approved In Canada
Omnitrope® (Sandoz) (April-2009)
Biosimilars Approved In The E.U.
Omnitrope® (Sandoz) (April-2006)
Biosimilars Approved In Australia
Omnitrope® (Sandoz) (September-2010)
Biosimilars Approved In Japan
Somatropin BS (Sandoz) (June-2009)
Biosimilars Approved In South Korea
Omnitrope® (Sandoz) (June-2009)