Omnitrope Approval History
- FDA approved: Yes (First approved May 30th, 2006)
- Brand name: Omnitrope
- Generic name: somatropin (rDNA origin)
- Company: Sandoz
- Treatment for: Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency
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.
FDA Approval History for Omnitrope
|Sep 3, 2008||Sandoz Receives FDA Approval for Omnitrope Pen 10 With Liquid Cartridge|
|Sep 14, 2005||Sandoz Files Lawsuit Seeking FDA Ruling on Omnitrope|
|Sep 2, 2004||FDA 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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.