FDA accepts for review NVS’ 351(k) Neupogen-FoB submission: http://www.novartis.com/newsroom/media-releases/en/2014/1835571.shtml This is the first 351(k) submission ever accepted by the FDA. 351(k) is the designation for the FoB-approval pathway established in 2010 as part of the ObamaCare legislation (#msg-48581353). NVS’ Neupogen FoB is already marketed in more than 40 countries under the brand name, Zarzio.