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FDA Clears Ferring Pharmaceuticals to Change Name of Growth Hormone, Device
31 March 2015 - - The US Food and Drug Administration has approved a name change enabling Swiss pharmaceutical company Ferring Pharmaceuticals Inc.'s newly acquired recombinant human growth hormone to be marketed in the US as Zomacton [somatropin (rDNA origin)] for injection, and its needle-free delivery system to be marketed in the US as Zoma-Jet, the company said on Tuesday. Ferring purchased the US rights to Zomacton, formerly Tev-Tropin, and to Zoma-Jet, formerly Tjet, in December 2014 from Israeli drugmaker Teva Pharmaceutical Industries Ltd. The comapny developed and has marketed Zomacton outside of the US since 1988 and in 47 countries globally. In the US, Zomacton is indicated for the treatment of children who have growth failure due to an inadequate secretion of normal endogenous growth hormone. Growth hormone deficiency in children can lead to short stature and delayed puberty. An estimated one in 4,000 to 10,000 children has GHD, and with early detection and treatment, many of these children can reach a normal height. Zomacton is expected to be available in the US in 2Q15 as both a five and ten milligram option, with the 10mg dose in a pre-filled diluent syringe. In addition, the Zoma-Jet needle-free administration device is expected to be available for the 5mg dose and in a new 10mg dose later this year.
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