Replies to post #186123 on Biotech Values

[DewDiligence]

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.)