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Re: DewDiligence post# 29369

Thursday, 06/25/2009 9:20:29 AM

Thursday, June 25, 2009 9:20:29 AM

Post# of 257257
First FoB approved in Japan: hGH from NVS:

http://www.reuters.com/article/marketsNews/idINLP48565720090625

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.


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