Omnitrope Approval History
FDA Approved: Yes (First approved May 30, 2006)
Brand name: Omnitrope
Generic name: somatropin (rDNA origin)
Dosage form: Injection
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.
Development History and FDA Approval Process 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|
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