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FDA approves new strength of Omnitrope

Executive Summary

FDA approves Sandoz's sNDA for a new strength cartridge (10 mg/1.5 mL) of Omnitrope's liquid formulation for use with a new reusable injector pen, Omnitrope Pen 10. The injector pen formulation of the follow-on human growth hormone, modeled after Pfizer's Genotropin, was first approved in January in a 5 mg strength (1"The Pink Sheet," Jan. 28, 2008, p. 10). Critics at first lambasted the delivery system, pointing out the difficulty in giving children daily injections. Sandoz says that the 10 mg version will offer more extensive dosing options because the cartridge needs to be refilled less often, providing doctors more flexibility with treatment options

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