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Omnitrope FDA Approval History

FDA Approved: Yes (First approved May 30, 2006)
Brand name: Omnitrope
Generic name: somatropin (rDNA origin)
Dosage form: Injection
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.

Development timeline 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

Further information

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