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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.

FDA Approval History for Omnitrope

DateArticle
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

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