Skip to Content

Omnitrope Approval History

Omnitrope (somatropin) is a recombinant human growth hormone indicated for treatment of children with growth failure due to growth hormone deficiency GHD and treatment of adults with either adult onset or childhood onset GHD.

Development History and FDA Approval Process for Omnitrope

Sep  3, 2008Approval Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge
Sep 14, 2005Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope
Sep  2, 2004FDA Defers Decision on Omnitrope Application

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.