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DewDiligence

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DewDiligence

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Re: genisi post# 186123

Friday, 03/06/2015 9:30:16 AM

Friday, March 06, 2015 9:30:16 AM

Post# of 251799
FDA approves NVS’ Zarxio (NeupogenFoB), the first FDA approval under the 351(k) FoB pathway:

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm436648.htm

The FDA label for Zarxio includes all five indications for which branded Neupogen is indicated. (This is one of the main reasons to use the 351(k) pathway rather than the conventional BLA pathway for an FoB.)

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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