This is the drug that goes by the name, Omnitrope, in the US. It was approved by the FDA under a 505b2 NDA after NVS sued the FDA to force it to take action (#msg-11358021, #msg-10688700).
Omnitrope has also been approved in the EU, as have FoB versions of EPO and G-CSF.
“The efficient-market hypothesis may be the foremost piece of B.S. ever promulgated in any area of human knowledge!”